510(k) K905375 ยท EZN Dilator, Catheter, Ureteral
ACCENT DG BALLOON URETERAL DILATOR SET
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Apr 12, 1991 |
| Received | Nov 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905375
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.