GORE INFINIT MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K081069
Device Name GORE INFINIT MESH
Applicant
W.L. GORE & ASSOCIATES,INC
301 airport rd.
elkton, 
MD 
21921

Applicant Contact michael j titus
Correspondent
W.L. GORE & ASSOCIATES,INC
301 airport rd.
elkton, 
MD 
21921

Correspodent Contact michael j titus
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 04/15/2008
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No