510(k) K140516 ยท FMI Needle, Hypodermic, Single Lumen
Terumo Pen Injector Needle 34
| Applicant | Kofu Factory of Terumo Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 5, 2014 |
| Received | Feb 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140516
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.