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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 K012419
Device Name CONFORM SHEETING, MODEL IGEL
Applicant
Implantech Associates, Inc.
2064 Eastman Ave., Unit 101
Ventura,  CA  93003
Applicant Contact STEPHEN MEADE
Correspondent
Implantech Associates, Inc.
2064 Eastman Ave., Unit 101
Ventura,  CA  93003
Correspondent Contact STEPHEN MEADE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received07/30/2001
Decision Date 10/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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