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Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

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Page 1: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 2: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 3: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 4: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 5: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 6: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 7: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 8: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 9: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 10: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 11: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 12: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 13: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 14: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 15: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 16: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 17: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 18: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 19: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 20: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4)

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 21: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 22: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4)

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 23: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4)

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 24: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 25: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 26: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 27: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 28: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 29: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Description

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 30: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Description

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 31: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 32: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 33: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 34: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 35: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 36: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 37: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 38: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Device Change Overview

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 39: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 40: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Sterilization and Shelf Life Information

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 41: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 42: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Testing

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 43: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Testing

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 44: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Testing

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 45: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Testing

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 46: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Testing

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 47: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Design

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 48: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 49: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 50: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Engineering Drawings

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 51: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Engineering Drawings

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 52: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 53: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 54: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 55: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 56: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 57: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 58: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 59: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 60: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 61: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 62: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 63: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 64: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 65: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

Page 66: Records Processed under FOI request 2017-5742; Released …Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018 Questions Contact FDA/CDRH/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Biocompatibility

Records Processed under FOI request 2017-5742; Released by CDRH on 08/20/2018

Questions Contact FDA/CDRH/DID at [email protected] or 301-796-8118

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4) Biocompatibility

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4) Device Modification ODE Review Memo

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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(b) (4)

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