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Surgical Masks - Premarket Notification [510(k)] Submissions

Surgical Masks - Premarket Notification [510(k)] ... In 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 ...

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Medical Face Masks - Buy Disposable Face Mask,3 Ply ...

Jul 04, 2020 · Jiangxi Sanxin Medtec Co. established in March 1997,focuses on researching and developing,manufacturing and marketing of medical devices.The company is one of first companies in the same trade of China which obtains CE and CMD certificates for products quality and quality management system,and gets FDA 510(K) premarketing approval in the United States.

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N95 Respirators and Surgical Masks (Face Masks) | FDA

N95 respirators and surgical masks (face 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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