510(k) K080508 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
MANDREL GUIDEWIRES OR M-WIRE
| Applicant | Lake Region Medical, Chaska MN, US |
| Decision | Substantially Equivalent, Mar 21, 2008 |
| Received | Feb 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080508
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.