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510K Summary - Food and Drug Administration

May 17, 2011 · 510(k) for ASTM F2100 Level 2 and Level 3 Face Mask(s) KC300 face mask(s) is a s ingle use, disposable device(s), provided non-sterile. Technological The Kimberly-Clark KC200 and K C300 face mask(s) are Characteristics and substantially equivalent Surgical Masks - Premarket Notification [510(k disposable fda 510k custom decorated surgical face masksThe surgical masks referenced in this guidance document include masks that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without a face shield. Surgical disposable fda 510k custom decorated surgical face masksDisposable FDA 510K/En14683 Decorated Custom Mask, Face Mask, Surgical Mask manufacturer / supplier in China, offering Disposable FDA 510K/En14683 Decorated Custom Medical Face Masks, Disposable HDPE LDPE Waterproof Apron Food Kitchen PE Apron, Disposable Shoe Cover/Non-Slip Shoe Covers and so on.

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