DIMISIL SCAR GEL


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K023678
Device Name DIMISIL SCAR GEL
Original Applicant
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
5871 lone pine place
paso robles, 
CA 
93446

Original Contact catherine riple
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 11/01/2002
Decision Date 01/23/2003
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

No