510(k) K192222 ยท FMI Needle, Hypodermic, Single Lumen
EZ-Inject Single use Needle
| Applicant | Poonglim Pharmatech, Inc., Gunsan, KR |
| Decision | Substantially Equivalent, May 12, 2020 |
| Received | Aug 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192222
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.