510(k) K152334 ยท FMI Needle, Hypodermic, Single Lumen
Sungshim Insulin Pen Needle
| Applicant | Sung Shim Medicare Co., Ltd., Sejing-Si, KR |
| Decision | Substantially Equivalent, Mar 17, 2016 |
| Received | Aug 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152334
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.