510(k) K190538 ยท FMI Needle, Hypodermic, Single Lumen
NIO-I
| Applicant | Waismed, Ltd., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Oct 7, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190538
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.