510(k) K172483 ยท FMI Needle, Hypodermic, Single Lumen
Kopac Sterile Needle
| Applicant | Poonglim Pharmatech, Inc., Gunsan, KR |
| Decision | Substantially Equivalent, Jun 21, 2018 |
| Received | Aug 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172483
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.