510(k) K033333 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
| Applicant | Aomori Olympus Co., Ltd., Melville NY, US |
| Decision | Substantially Equivalent, Nov 14, 2003 |
| Received | Oct 16, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033333
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.