510(k) K062805 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
MODIFICATION TO ENDO-EASE
| Applicant | Spirus Medical, Inc., Ayer MA, US |
| Decision | Substantially Equivalent, Oct 13, 2006 |
| Received | Sep 19, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062805
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.