GILTECH PLUS HYDROGEL SKIN DRESSING


Device Classification Name

dressing, wound and burn, hydrogel w/drug and/or biologic

510(k) Number K992094
Device Name GILTECH PLUS HYDROGEL SKIN DRESSING
Applicant
GILTECH PLUS, INC.
p.o. box 728
milford, 
PA 
18337

Applicant Contact william j giliam
Correspondent
GILTECH PLUS, INC.
p.o. box 728
milford, 
PA 
18337

Correspodent Contact william j giliam
Classification Product Code
MGQ  
Date Received 06/21/1999
Decision Date 09/17/1999
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No