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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 K024057
Device Name CURAD SCAR THERAPY
Applicant
Beiersdorf, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact FRANCES K WU
Correspondent
Beiersdorf, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact FRANCES K WU
Regulation Number878.4025
Classification Product Code
MDA  
Date Received12/09/2002
Decision Date 06/18/2003
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 Yes
Predetermined Change
Control Plan Authorized		 No
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