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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 K962013
Device Name MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
Applicant
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Applicant Contact LYNN BRECKENRIDGE
Correspondent
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Correspondent Contact LYNN BRECKENRIDGE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/23/1996
Decision Date 08/22/1996
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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