510(k) K171144 ยท FMI Needle, Hypodermic, Single Lumen
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
| Applicant | Medbio, LLC, Cooper City FL, US |
| Decision | Substantially Equivalent, Sep 12, 2017 |
| Received | Apr 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171144
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.