The following data is part of a premarket notification filed by M.i. Tech Co., Ltd with the FDA for Hanarostent Esophagus Tts (ccc), Hanarostent Esophagus Tts (ncn).
| Device ID | K200860 |
| 510k Number | K200860 |
| Device Name: | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) |
| Classification | Prosthesis, Esophageal |
| Applicant | M.I. Tech Co., Ltd 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si, KR 17706 |
| Contact | Inae Kim |
| Correspondent | Beryl St. Jeanne NAMSA 400 Highway 169 South Suite 500 Minneapolis, MN 55426 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-05-20 |