510(k) K093537 ยท ESW Prosthesis, Esophageal
HANAROSTENT ESOPHAGUS (CCC)
| Applicant | M.I.Tech Co., Ltd., Buena Park CA, US |
| Decision | Substantially Equivalent, Jun 4, 2010 |
| Received | Nov 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093537
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.