510(k) K973113 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 10, 1997 |
| Received | Aug 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973113
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.