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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K053481
Device Name KELO-COTE SPRAY
Applicant
Advanced Bio-Technologies, Inc.
P.O.Box 3515
Redmond,  WA  98073
Applicant Contact STEVEN CHERNOFF
Correspondent
Advanced Bio-Technologies, Inc.
P.O.Box 3515
Redmond,  WA  98073
Correspondent Contact STEVEN CHERNOFF
Regulation Number878.4025
Classification Product Code
MDA  
Date Received12/14/2005
Decision Date 04/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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