510(k) K230635 ยท FMI Needle, Hypodermic, Single Lumen
Pen Needle
| Applicant | Jiangsu Caina Medical Co.,Ltd, Jiangyin, CN |
| Decision | Substantially Equivalent, Jun 2, 2023 |
| Received | Mar 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230635
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.