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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K140147
Device Name BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
Applicant
Bio-Medical Carbon Technology Co., Ltd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact DIANE SUDDUTH
Correspondent
Bio-Medical Carbon Technology Co., Ltd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact DIANE SUDDUTH
Classification Product Code
FRO  
Date Received01/22/2014
Decision Date 04/22/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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