510(k) K152877 ยท FMI Needle, Hypodermic, Single Lumen
SureFine Pen Needle
| Applicant | Shina Med Corporation, Anseong-Si, KR |
| Decision | Substantially Equivalent, Jun 7, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152877
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.