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Masks. Masks are essential during surgical operation and for other medical purposes. Face masks are recommended by FDA and other health organizations. Facemasks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the facemask, discard it safely, and replace it with a new one.

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510K Summary Food and Drug Administration

2011 11 28 · 510K Summary Date Summary was May 17, 2011 Prepared610(k) SubmitterAnn Waterhouse, RAC Associate Director of Regulatory Affairs Roswell, GA 30076 678 352 671 9 (telephone) 920 225 3108 (facsimile) Ann.waterhouse(&kcc Device Trade NameKG 200 Face Mask KG 300 Face Mask Device Common names Mask, surgical Device Product FXX, Class 11

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(Mask, Surgical) FDA 510(k) Applications Database

CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS10/03/1988K883827GREENE INTERNATIONAL CORP. MASKS, VARIOUS TYPES OF SURGICAL MASKS11/17/1988K093179H&H RESEARCH COMPANYMEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) 07/14/2010K143287Halyard Health, Inc. Fluidshield* Surgical Mask with Expanded

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