510(k) K230043 ยท FMI Needle, Hypodermic, Single Lumen
Insulin Pen Needle
| Applicant | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., Anqing, CN |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Jan 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230043
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.