CICACARE MANAGEMENT FOR SCARS


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K991957
Device Name CICACARE MANAGEMENT FOR SCARS
Applicant
SMITH & NEPHEW, INC.
11775 starkey rd.
largo, 
FL 
33773 -4727

Applicant Contact jim irvin
Correspondent
SMITH & NEPHEW, INC.
11775 starkey rd.
largo, 
FL 
33773 -4727

Correspodent Contact jim irvin
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 06/10/1999
Decision Date 07/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No