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The top documents tagged [premarket submission]
Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering
[email protected]
Director, International Staff US Food and Drug Administration
225 views
Regulatory Pathway for Platform Technologies Quynh Hoang Neurotherapeutic and Neurodiagnostic Devices Branch Division of Ophthalmic, Neurological and Ear,
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FDA 510K Clearance Certification K040445 Propoxyphene (PPX) Drug Screening Kits
218 views