510(k) K213183 ยท FMI Needle, Hypodermic, Single Lumen
Safety Insulin Pen Needles
| Applicant | Zhejiang Kindly Medical Devices Co., Ltd., Wenzhou, CN |
| Decision | Substantially Equivalent, Oct 14, 2022 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213183
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.