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Surgical Masks - Premarket Notification [510(k)] Submissions | FDA Surgical Masks - Premarket Notification [510(k)] Submissions Guidance for ... U.S. Department of Health and Human Services ... Back to the top ... (See also 21 CFR 820.30, Subpart C - Design Controls under the Quality System Regulation.) ...

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Verifying Certificates for Masks, Gloves, and Other PPE from China ... 10 Apr 2020 ... Starting with face masks — both a high-demand and high-risk item. ... Prior submission of a premarket notification under section 510(k) of the FD&C Act ... Quality System Regulation requirements in 21 CFR 820,; Reports or corrections ... Regarding medical respirators, the FDA provides a helpful page here ...

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