510(k) K180028 ยท EZN Dilator, Catheter, Ureteral
Cook 810 Set, Desilets-Hoffman Introducer Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 2, 2018 |
| Received | Jan 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180028
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.