510(k) K151311 ยท FMI Needle, Hypodermic, Single Lumen
Safe Block Pen Needle
| Applicant | Artsana S.P.A, Grandate, IT |
| Decision | Substantially Equivalent, Feb 10, 2016 |
| Received | May 18, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K151311
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.