510(k) K914495 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
E.R.C.P. CATHETER
| Applicant | Surgitek Medical Engineering Corp., Racine WI, US |
| Decision | Substantially Equivalent, Jan 30, 1992 |
| Received | Oct 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914495
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.