510(k) K171982 ยท FMI Needle, Hypodermic, Single Lumen
DROPLET PEN NEEDLE
| Applicant | Htl-Strefa S.A, Ozorkow, PL |
| Decision | Substantially Equivalent, Mar 21, 2018 |
| Received | Jun 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171982
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.