510(k) K201160 ยท ESW Prosthesis, Esophageal
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
| Applicant | M.I.Tech Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Jul 23, 2021 |
| Received | Apr 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201160
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.