510(K) Modifications

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Press Releases and Statements

For the first time, the U.S. Food and Drug Administration (FDA) has assembled a comprehensive webpage with Consumer Medical Device information

Sep 14, 2021

Submission

Enclosed herein are comments on "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: Public Meeting: Request for Comments".

Jul 12, 2013

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