510(k) K191488 · FMI Needle, Hypodermic, Single Lumen
SAM IO Intraosseous Access System
| Applicant | Sam® Medical Products, Inc., Wilsonville OR, US |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Jun 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191488
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.