SCAREASE SHEETS & SCAREASE GEL

Device Classification Name

elastomer, silicone, for scar management

510(k) Number K991970
Device Name SCAREASE SHEETS & SCAREASE GEL
Applicant
PILLAR SURGICAL
po box 8141
la jolla, 
CA 
92038

Applicant Contact rob fritzenkotter
Correspondent
PILLAR SURGICAL
po box 8141
la jolla, 
CA 
92038

Correspodent Contact rob fritzenkotter
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 06/11/1999
Decision Date 10/25/1999
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