510(k) K983154 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
CYSTIC DUCT BALLOON DILATING CATHETER
| Applicant | Applied Medical Resources, Launa Hills CA, US |
| Decision | Substantially Equivalent, May 5, 1999 |
| Received | Sep 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983154
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.