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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 K954413
Device Name KELOCOTE
Applicant
Allied Biomedical Corp.
3850 Dr.
#C-2
Paso Robles,  CA  93446
Applicant Contact CATHY RIPPLE
Correspondent
Allied Biomedical Corp.
3850 Dr.
#C-2
Paso Robles,  CA  93446
Correspondent Contact CATHY RIPPLE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received09/21/1995
Decision Date 11/29/1995
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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