510(k) K211395 ยท FMI Needle, Hypodermic, Single Lumen
NIO-I
| Applicant | Einstein Works, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Jul 28, 2021 |
| Received | May 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211395
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.