510(k) K900904 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, May 11, 1990 |
| Received | Feb 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900904
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.