510(k) K182144 ยท KNY Accessories, Catheter, G-U
Bi-Flex Evo
| Applicant | Promepla Sam, Monaco, MC |
| Decision | Substantially Equivalent, Sep 7, 2018 |
| Received | Aug 8, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182144
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.