510(k) K190962 ยท FMI Needle, Hypodermic, Single Lumen
Bella-mu
| Applicant | U-Needle B.V., Enschede, NL |
| Decision | Substantially Equivalent, Feb 3, 2020 |
| Received | Apr 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190962
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.