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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 K952612
Device Name DURASIL
Applicant
The S. F. Group, Inc.
304 W. Main St.
Grand Junction,  CO  81505
Applicant Contact LEE A WHITNEY III
Correspondent
The S. F. Group, Inc.
304 W. Main St.
Grand Junction,  CO  81505
Correspondent Contact LEE A WHITNEY III
Regulation Number878.4025
Classification Product Code
MDA  
Date Received06/07/1995
Decision Date 11/22/1995
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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