510(k) K132181 ยท EZN Dilator, Catheter, Ureteral
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
| Applicant | Olympus Surgical Technologies America, Southborough MA, US |
| Decision | Substantially Equivalent, Oct 21, 2013 |
| Received | Jul 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132181
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.