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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 K010675
Device Name ENSIL FABRIC
Applicant
Gottfried Medical, Inc.
4105 W. Alexis Rd.
Toledo,  OH  43623
Applicant Contact BRENT M GOTTFRIED
Correspondent
Gottfried Medical, Inc.
4105 W. Alexis Rd.
Toledo,  OH  43623
Correspondent Contact BRENT M GOTTFRIED
Regulation Number878.4025
Classification Product Code
MDA  
Date Received03/06/2001
Decision Date 05/30/2001
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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