510(k) K192464 ยท FMI Needle, Hypodermic, Single Lumen
Injection Pen Needle
| Applicant | Gangan Medical Technology Jiangsu Co., Ltd., Taizhou City, CN |
| Decision | Substantially Equivalent, Aug 25, 2020 |
| Received | Sep 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192464
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.