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NBC Meshtec Cufitec® Surgical Mask 510(k) Summary Traditional 510(k) Submission Page 5-2 . 4: DEVICE DESCRIPTION . The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and

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