510(k) K181069 ยท FMI Needle, Hypodermic, Single Lumen
Disposable Insulin Pen Needle
| Applicant | Zhejiang Kindly Medical Devices Co., Ltd., Wenzhou, CN |
| Decision | Substantially Equivalent, Aug 28, 2018 |
| Received | Apr 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181069
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.