510(k) K180291 ยท LKF Cannula, Manipulator/Injector, Uterine
Cook Silicone Balloon HSG Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 26, 2018 |
| Received | Feb 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180291
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.