AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT


Device Classification Name

staple, implantable

510(k) Number K080898
Device Name AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
Applicant
TYCO HEALTHCARE GROUP, LP
60 middletown ave.
north haven, 
CT 
06473

Applicant Contact sharon alexander
Correspondent
TYCO HEALTHCARE GROUP, LP
60 middletown ave.
north haven, 
CT 
06473

Correspodent Contact sharon alexander
Regulation Number 878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received 03/31/2008
Decision Date 05/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls