510(k) K190141 ยท MQR Stent, Colonic, Metallic, Expandable
HANAROSTENT LowAx Colon/Rectum (NNN)
| Applicant | M.I.Tech Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Mar 7, 2019 |
| Received | Jan 29, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190141
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.