The following data is part of a premarket notification filed by M.i.tech Co., Ltd. with the FDA for Hanarostent Benefit Biliary (nnn).
| Device ID | K202973 |
| 510k Number | K202973 |
| Device Name: | HANAROSTENT Benefit 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 | Kelly Kucharczyk Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806367093080 | K202973 | 000 |
| 08806367092892 | K202973 | 000 |
| 08806367092885 | K202973 | 000 |
| 08806367092878 | K202973 | 000 |
| 08806367092861 | K202973 | 000 |
| 08806367092854 | K202973 | 000 |
| 08806367092847 | K202973 | 000 |
| 08806367092830 | K202973 | 000 |
| 08806367092823 | K202973 | 000 |
| 08806367092816 | K202973 | 000 |
| 08806367092809 | K202973 | 000 |
| 08806367092793 | K202973 | 000 |
| 08806367092786 | K202973 | 000 |
| 08806367092779 | K202973 | 000 |
| 08806367092762 | K202973 | 000 |
| 08806367092755 | K202973 | 000 |
| 08806367092748 | K202973 | 000 |
| 08806367092908 | K202973 | 000 |
| 08806367092915 | K202973 | 000 |
| 08806367093073 | K202973 | 000 |
| 08806367093066 | K202973 | 000 |
| 08806367093059 | K202973 | 000 |
| 08806367093042 | K202973 | 000 |
| 08806367093035 | K202973 | 000 |
| 08806367093028 | K202973 | 000 |
| 08806367093011 | K202973 | 000 |
| 08806367093004 | K202973 | 000 |
| 08806367092991 | K202973 | 000 |
| 08806367092984 | K202973 | 000 |
| 08806367092977 | K202973 | 000 |
| 08806367092960 | K202973 | 000 |
| 08806367092953 | K202973 | 000 |
| 08806367092946 | K202973 | 000 |
| 08806367092939 | K202973 | 000 |
| 08806367092922 | K202973 | 000 |
| 08806367092731 | K202973 | 000 |