510(k) K945498 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
| Applicant | Instent, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 12, 1995 |
| Received | Nov 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945498
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.