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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 K914701
Device Name SIL-K
Applicant
DEGANIA SILICONE, LTD.
degania bet
emek hayarden,  IL 15130
Applicant Contact bette lubin
Correspondent
DEGANIA SILICONE, LTD.
degania bet
emek hayarden,  IL 15130
Correspondent Contact bette lubin
Regulation Number878.4025
Classification Product Code
MDA  
Date Received10/18/1991
Decision Date 01/31/1992
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
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