CURAD SCAR THERAPY


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K024057
Device Name CURAD SCAR THERAPY
Original Applicant
BEIERSDORF, INC.
700 thirteenth street, n.w.
suite 1200
washington, 
DC 
20005 -5929

Original Contact frances k wu
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 12/09/2002
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