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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 K251967
Device Name HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
Applicant
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Applicant Contact Anureet Singh
Correspondent
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Correspondent Contact Anureet Singh
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/26/2025
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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