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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 K002488
FOIA Releasable 510(k) K002488
Device Name KELO-COTE TOPICAL GEL
Applicant
Advanced Bio-Technologies, Inc.
53 Needham Dr.
Suite 5, Cw4 8fb
Cranage, Cheshire,  GB CW4 8FB
Applicant Contact DAVID BRYANT
Correspondent
Advanced Bio-Technologies, Inc.
53 Needham Dr.
Suite 5, Cw4 8fb
Cranage, Cheshire,  GB CW4 8FB
Correspondent Contact DAVID BRYANT
Regulation Number878.4025
Classification Product Code
MDA  
Date Received08/14/2000
Decision Date 01/05/2001
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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