510(k) K092156 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
CAD 12, COLONOSCOPY ASSIST DEVICE
| Applicant | Softscope Medical Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 14, 2009 |
| Received | Jul 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092156
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.