510(k) K143609 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
| Applicant | Olympus Surgical Technologies America, Southborough MA, US |
| Decision | Substantially Equivalent, Mar 27, 2015 |
| Received | Dec 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143609
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.