The following data is part of a premarket notification filed by M.i. Tech Co., Ltd. with the FDA for Hanarostent Lowaxtm Colon/rectum (nnn), Hanarostent Lowaxtm Duodenum/pylorus (nnn).
| Device ID | K180180 |
| 510k Number | K180180 |
| Device Name: | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | M.I. Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si, KR 17706 |
| Contact | Inae Kim |
| Correspondent | Carol Buchert NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-11-02 |
| Summary: | summary |