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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 K200824
Device Name Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
Applicant
Cardinal Health200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Caroline Miceli
Correspondent
Cardinal Health200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Caroline Miceli
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/30/2020
Decision Date 07/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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