510(k) K211634 ยท FMI Needle, Hypodermic, Single Lumen
Hypodermic Needle-Pro EDGE Safety Device
| Applicant | Smiths Medical Asd, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | May 27, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211634
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.