510(k) K080050 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
| Applicant | Spirus Medical, Inc., Ayer MA, US |
| Decision | Substantially Equivalent, May 6, 2008 |
| Received | Jan 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080050
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.