510(k) K163578 ยท FMI Needle, Hypodermic, Single Lumen
EasyTouch Safety Pen Needle
| Applicant | Mhc Medical Products, LLC, Fairfield OH, US |
| Decision | Substantially Equivalent, Aug 3, 2018 |
| Received | Dec 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163578
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.