510(k) K143437 ยท FMI Needle, Hypodermic, Single Lumen
Droplet Pen Needles
| Applicant | Htl-Strefa S.A, Ozorkow, PL |
| Decision | Substantially Equivalent, Jun 25, 2015 |
| Received | Dec 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143437
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.