510(k) K942578 ยท EZN Dilator, Catheter, Ureteral
ENTRAC URETERAL BALLOON DILATATION CATHETERS
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Aug 19, 1994 |
| Received | May 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942578
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.