510(k) K170768 ยท FMI Needle, Hypodermic, Single Lumen
Mini Needle
| Applicant | Ocuject, LLC, Newport Beach CA, US |
| Decision | Substantially Equivalent, Jul 10, 2017 |
| Received | Mar 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170768
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.