510(k) K112332 ยท FMI Needle, Hypodermic, Single Lumen
FINE JECT INSULIN PEN NEEDLE
| Applicant | Twobiens Co., Ltd., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jan 10, 2012 |
| Received | Aug 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112332
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.