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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on March 5, 2004 and a correction posted on July 14, 2004.

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