GORE-TEX DUALMESH BIOMATERIAL


Device Classification Name

mesh, surgical, polymeric

510(k) Number K992189
Device Name GORE-TEX DUALMESH BIOMATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
301 airport rd
elkton, 
MD 
21922 -1408

Applicant Contact r, larry pratt
Correspondent
W.L. GORE & ASSOCIATES,INC
301 airport rd
elkton, 
MD 
21922 -1408

Correspodent Contact r, larry pratt
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 06/29/1999
Decision Date 07/29/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized