FINE JECT INSULIN PEN NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K112332
Device Name FINE JECT INSULIN PEN NEEDLE
Applicant
TWOBIENS CO., LTD.
300 atwood
pittsburgh, 
PA 
15213

Applicant Contact peter chung
Correspondent
TWOBIENS CO., LTD.
300 atwood
pittsburgh, 
PA 
15213

Correspodent Contact peter chung
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 08/12/2011
Decision Date 01/10/2012
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