510(k) K143303 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Single Use Biliary Balloon Dilator
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Feb 27, 2015 |
| Received | Nov 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143303
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.