The following data is part of a premarket notification filed by Twobiens Co., Ltd. with the FDA for Fine Ject Insulin Pen Needle.
| Device ID | K112332 |
| 510k Number | K112332 |
| Device Name: | FINE JECT INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TWOBIENS CO., LTD. 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung TWOBIENS CO., LTD. 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2012-01-10 |
| Summary: | summary |