DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER


Device Classification Name

staple, implantable

510(k) Number K121474
Device Name DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
Applicant
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
77325 joyce way
echo, 
OR 
97826

Applicant Contact charles mack
Correspondent
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
77325 joyce way
echo, 
OR 
97826

Correspodent Contact charles mack
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 05/18/2012
Decision Date 07/16/2012
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