510(k) K250658 ยท FMI Needle, Hypodermic, Single Lumen
SureFine Pen Needle
| Applicant | Shina Med Corporation, Anseong, KR |
| Decision | Substantially Equivalent, Apr 3, 2025 |
| Received | Mar 5, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250658
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.