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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K160339
FOIA Releasable 510(k) K160339
Device Name Cardinal Health Isolation 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
FYC  
Date Received02/08/2016
Decision Date 07/28/2016
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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