510(k) K182511 ยท GBM Catheter, Urethral
SimplCath
| Applicant | F&S Medical Solutions, LLC, Omaha NE, US |
| Decision | Substantially Equivalent, Mar 20, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182511
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.