510(k) K202319 ยท FMI Needle, Hypodermic, Single Lumen
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
| Applicant | Tianjin Huahong Technology Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Nov 12, 2021 |
| Received | Aug 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202319
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.