ECHELON GRAY CARTRIDGE, MODEL ERC45M


Device Classification Name

staple, implantable

510(k) Number K080839
Device Name ECHELON GRAY CARTRIDGE, MODEL ERC45M
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Applicant Contact ruth ann wood
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Correspodent Contact ruth ann wood
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 03/25/2008
Decision Date 05/21/2008
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