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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 K232824
Device Name FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
Applicant
Owens & Minor (O&M) Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Caitlin Senter
Correspondent
Owens & Minor (O&M) Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Correspondent Contact Caitlin Senter
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/13/2023
Decision Date 07/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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