510(k) K213407 ยท FMI Needle, Hypodermic, Single Lumen
UltiCare Disposable Pen Needles
| Applicant | Ultimed Incorporated, Excelsior MN, US |
| Decision | Substantially Equivalent, Dec 16, 2021 |
| Received | Oct 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213407
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.