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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 K901991
Device Name SILICONE ELASTOMER PUTTY
Applicant
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Applicant Contact LAURENCE COLIN
Correspondent
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Correspondent Contact LAURENCE COLIN
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/02/1990
Decision Date 09/14/1990
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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