510(k) K183616 ยท MQR Stent, Colonic, Metallic, Expandable
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
| Applicant | M.I.Tech Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Jan 10, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183616
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.