510(k) K915392 ยท EZN Dilator, Catheter, Ureteral
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Mar 18, 1992 |
| Received | Nov 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915392
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.