510(k) K160575 ยท FMI Needle, Hypodermic, Single Lumen
CareSens Pen Needle, Softip Pen Needle
| Applicant | Yidobio, Inc., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Sep 7, 2016 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160575
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.