SILGEL TOPICAL GEL SHEET


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K960254
Device Name SILGEL TOPICAL GEL SHEET
Applicant
ROFIL MEDICAL USA, INC.
26856 oak hollow rd.
p.o. box 2036
laguna hills, 
CA 
92653 -2036

Applicant Contact william e stovall
Correspondent
ROFIL MEDICAL USA, INC.
26856 oak hollow rd.
p.o. box 2036
laguna hills, 
CA 
92653 -2036

Correspodent Contact william e stovall
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 01/17/1996
Decision Date 04/02/1996
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