510(k) K901433 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
| Applicant | Telemed Systems, Inc., Hudson MA, US |
| Decision | Substantially Equivalent, Jun 21, 1990 |
| Received | Mar 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901433
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.