KDL DISPOSABLE INFUSION SET


Device Classification Name

set, administration, intravascular

510(k) Number K112204
Device Name KDL DISPOSABLE INFUSION SET
Applicant
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 08/01/2011
Decision Date 09/10/2012
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