510(k) K160199 ยท FMI Needle, Hypodermic, Single Lumen
Advocate Insulin Pen Needles
| Applicant | Diabetic Supply of Suncoast, Inc., Dorado PR, US |
| Decision | Substantially Equivalent, Oct 19, 2016 |
| Received | Jan 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160199
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.