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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K143287
Device Name Fluidshield* Surgical Mask with Expanded Chamber
Applicant
Halyard Health, Inc.
5405 Windward Pkwy
Alpharetta,  GA  30004
Applicant Contact Roberto F. Refeca
Correspondent
Halyard Health, Inc.
5405 Windward Pkwy
Alpharetta,  GA  30004
Correspondent Contact Roberto F. Refeca
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/17/2014
Decision Date 03/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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