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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K233022
Device Name Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
Applicant
Owens & Minor (O&M) Halyard, Inc.
9120 Lockwood Blvd
Mechanicsville,  VA  23116
Applicant Contact Anureet Singh
Correspondent
Owens & Minor (O&M) Halyard, Inc.
9120 Lockwood Blvd
Mechanicsville,  VA  23116
Correspondent Contact Anureet Singh
Regulation Number878.4040
Classification Product Code
MSH  
Date Received09/22/2023
Decision Date 01/12/2024
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
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