510(k) K082995 ยท KNQ Dilator, Esophageal
SMART DILATOR
| Applicant | Safestitch Medical, Miami FL, US |
| Decision | Substantially Equivalent, Feb 6, 2009 |
| Received | Oct 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082995
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.