DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR

Device Classification Name

staple, implantable

510(k) Number K131511
Device Name DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
Applicant
CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD
p.o. box 120-119
shanghai, 

CN

200120
Applicant Contact diana hong
Correspondent
CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD
p.o. box 120-119
shanghai, 

CN

200120
Correspodent Contact diana hong
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 05/28/2013
Decision Date 07/05/2013
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