DISPOSABLE INSULIN SYRINGE


Device Classification Name

syringe, piston

510(k) Number K110421
Device Name DISPOSABLE INSULIN SYRINGE
Applicant
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
p.o. box 237-023
bingyi xiang, zhejiang, 

CN

325000

Applicant Contact diana hong
Correspondent
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
p.o. box 237-023
bingyi xiang, zhejiang, 

CN

325000

Correspodent Contact diana hong
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 02/14/2011
Decision Date 04/26/2011
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