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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 K170762
Device Name Cardinal Health Non-Reinforced Surgical Gown
Applicant
Cardinal Health200, LLC
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Caroline Miceli
Correspondent
Cardinal Health200, LLC
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact Caroline Miceli
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/13/2017
Decision Date 06/09/2017
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
Recalls CDRH Recalls
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