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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.
Men Women Dust Mask Breathable Cotton Mouth Mask Washable Reusable Outdoor Windproof Half Face Masks Bike Cycling Face Mouth Cover $10.87 $ 10 . 87 ($3.62/Count) $5.00 shipping