510(k) K180720 ยท FMI Needle, Hypodermic, Single Lumen
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
| Applicant | Medibio USA, LLC, Cooper City FL, US |
| Decision | Substantially Equivalent, Jun 27, 2018 |
| Received | Mar 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180720
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.