510(k) K082589 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
| Applicant | Barosense, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 22, 2009 |
| Received | Sep 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082589
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.