DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL


Device Classification Name

mesh, surgical, polymeric

510(k) Number K022782
Device Name DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
Original Applicant
W.L. GORE & ASSOCIATES,INC
301 airport rd
elkton, 
MD 
21922 -1408

Original Contact r. larry pratt
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 08/22/2002
Decision Date 09/10/2002
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