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Surgical Masks Premarket Notification [510(kIn an Abbreviated 510(k), FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that youGet Price Reporfda 510k en14683 bird flu face masks size Surgical face Buy disposable FDA 510k bird flu fabric ...

Answers to frequently asked questions about face masks and surgical masks, including manufacturing, purchasing, importing, and donating masks during the COVID-19 public health emergency.

N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.

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Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.

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