510(k) K013737 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
| Applicant | Telemed Systems, Inc., Hudson MA, US |
| Decision | Substantially Equivalent, Mar 1, 2002 |
| Received | Nov 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013737
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.