510(k) K181447 ยท FMI Needle, Hypodermic, Single Lumen
Safety insulin needle for single use
| Applicant | Berpu Medical Technology Co., Ltd., Wenzhou, CN |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Jun 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181447
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.