510(k) K974815 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MANAN(TM) INTRODUCER SHEATH/NEEDLE
| Applicant | Medical Device Technologies, Inc., Gainsville FL, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974815
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.