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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 K913140
Device Name SILICONE GEL SHEETING
Applicant
Cui Corp.
P.O. Box 40288
Santa Barbara,  CA  93140
Applicant Contact ELLEN DUKE
Correspondent
Cui Corp.
P.O. Box 40288
Santa Barbara,  CA  93140
Correspondent Contact ELLEN DUKE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received07/16/1991
Decision Date 09/30/1991
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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