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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K192362
Device Name Aero Blue Performance Surgical Gowns
Applicant
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Kimberly Lewis
Correspondent
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Correspondent Contact Kimberly Lewis
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/30/2019
Decision Date 12/13/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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