510(k) K210059 ยท FMI Needle, Hypodermic, Single Lumen
Promisemed Insulin Pen Needle
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Jul 21, 2021 |
| Received | Jan 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210059
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.