510(k) K220129 ยท FMI Needle, Hypodermic, Single Lumen
Promisemed X-Safety Pen Needle
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Sep 19, 2022 |
| Received | Jan 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220129
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.