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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 K974172
Device Name SILGEL TOPICAL GEL SHEET
Applicant
Nagor , Ltd.
P.O. Box 21 Douglas
Isle Of Man Im99 1ax
British Isles,  VG
Applicant Contact J A EVANS
Correspondent
Nagor , Ltd.
P.O. Box 21 Douglas
Isle Of Man Im99 1ax
British Isles,  VG
Correspondent Contact J A EVANS
Regulation Number878.4025
Classification Product Code
MDA  
Date Received11/05/1997
Decision Date 03/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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