510(k) K050502 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SINGLE USE BALLOON DILATOR MAXPASSTM
| Applicant | Olympus Winter & Ibe GmbH, Melville NY, US |
| Decision | Substantially Equivalent, Jul 8, 2005 |
| Received | Feb 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050502
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.