REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET


Device Classification Name

staple, implantable

510(k) Number K103672
Device Name REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Applicant Contact dennis hahn
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Correspodent Contact dennis hahn
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 12/16/2010
Decision Date 04/08/2011
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