510(k) K182770 ยท FMI Needle, Hypodermic, Single Lumen
Adult Intraosseous Infusion Device
| Applicant | Einstein Works, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Apr 9, 2019 |
| Received | Sep 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182770
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.