The following data is part of a premarket notification filed by M.i.tech Co., Ltd. with the FDA for Hanarostent Fasttm Biliary (nnn).
| Device ID | K183396 |
| 510k Number | K183396 |
| Device Name: | HANAROSTENT FASTTM Biliary (NNN) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| 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 | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806367082053 | K183396 | 000 |
| 08806367073334 | K183396 | 000 |
| 08806367073341 | K183396 | 000 |
| 08806367073358 | K183396 | 000 |
| 08806367073365 | K183396 | 000 |
| 08806367073372 | K183396 | 000 |
| 08806367073389 | K183396 | 000 |
| 08806367073396 | K183396 | 000 |
| 08806367073693 | K183396 | 000 |
| 08806367073709 | K183396 | 000 |
| 08806367073716 | K183396 | 000 |
| 08806367073723 | K183396 | 000 |
| 08806367073730 | K183396 | 000 |
| 08806367073747 | K183396 | 000 |
| 08806367082022 | K183396 | 000 |
| 08806367082039 | K183396 | 000 |
| 08806367082046 | K183396 | 000 |
| 08806367073327 | K183396 | 000 |