510(k) K180180 ยท MQR Stent, Colonic, Metallic, Expandable
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
| Applicant | M.I.Tech Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Jan 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180180
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.