510(k) K953597 ยท EZN Dilator, Catheter, Ureteral
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
| Applicant | Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Oct 7, 1995 |
| Received | Aug 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953597
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.