MODIFICATION TO ENDOFAST RELIANT SYSTEM


Device Classification Name

mesh, surgical, polymeric

510(k) Number K080836
Device Name MODIFICATION TO ENDOFAST RELIANT SYSTEM
Applicant
ENDOGUN MEDICAL SYSTEMS
jabotinsky street 7
ramat gan, 

IL

52520

Applicant Contact dorit winitz
Correspondent
ENDOGUN MEDICAL SYSTEMS
jabotinsky street 7
ramat gan, 

IL

52520

Correspodent Contact dorit winitz
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 03/25/2008
Decision Date 04/21/2008
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