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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dress, Surgical
510(k) Number K894760
Device Name CLOTHINGUARD
Applicant
Barrier Concepts, Inc.
Post Office Box 11421
Columbia,  SC  29211
Applicant Contact STEVEN C HASTEROK
Correspondent
Barrier Concepts, Inc.
Post Office Box 11421
Columbia,  SC  29211
Correspondent Contact STEVEN C HASTEROK
Regulation Number878.4040
Classification Product Code
FYE  
Date Received07/27/1989
Decision Date 08/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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