510(k) K212514 ยท FMI Needle, Hypodermic, Single Lumen
Safety Pen Needle for Single Use, Insulin Pen Needles
| Applicant | Berpu Medical Technology Co., Ltd., Wenzhou, CN |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Aug 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212514
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.