M.I.Tech Co., Ltd. · Class II · Cleared Nov 2, 2018
| K-number | K180180 |
| Device name | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
| Applicant | M.I.Tech Co., Ltd. |
| Product code | MQR |
| Device class | Class II |
| Decision date | Nov 2, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 878.3610 |
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