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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 K150151
FOIA Releasable 510(k) K150151
Device Name SmartGownTM surgical gown
Applicant
Cardinal Health 200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60685
Applicant Contact Lavenia Ford
Correspondent
Cardinal Health 200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60685
Correspondent Contact Lavenia Ford
Regulation Number878.4040
Classification Product Code
FYA  
Date Received01/23/2015
Decision Date 05/21/2015
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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