510(k) K211214 ยท FMI Needle, Hypodermic, Single Lumen
Sterile Hypodermic Needles for Single Use
| Applicant | Azur Medical Company, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Oct 14, 2021 |
| Received | Apr 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211214
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.