510(k) K211716 · FMI Needle, Hypodermic, Single Lumen
DropSafe Safety Pen Needles
| Applicant | Htl Strefa SA, Ozorków, PL |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Jun 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211716
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.