KDL SYRINGES AND NEEDLE


Device Classification Name

syringe, piston

510(k) Number K112057
Device Name KDL SYRINGES AND NEEDLE
Applicant
SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received 07/19/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No