510(k) K970041 ยท EZN Dilator, Catheter, Ureteral
ASCEND BALLOON DAILATION CATHETER
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Jan 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970041
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.