Ophtec Usa

FDA Filings

This page includes the latest FDA filings for Ophtec Usa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMN K030471 OPHTEC USA	OPHTEC ENCLAVATION NEEDLE	2003-04-17

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OPHTEC USA, INC.
OPHTEC USA, INC.6421 Congress Ave., Suite 112boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

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