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510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. Christy Foreman Director Office of Device Evaluation. Purpose of this Guidance. First guidance was issued in 1997 (2 drafts before finalizing) To clarify when a new 510(k) is needed

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