510(k) K192082 ยท FMI Needle, Hypodermic, Single Lumen
Droplet Pen Needle 34G
| Applicant | Htl-Strefa S.A, Ozorkow, PL |
| Decision | Substantially Equivalent, Apr 21, 2020 |
| Received | Aug 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192082
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.