FDA Device Establishments · JSON-LD · Markdown
FEI 3011458193 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3011458193 |
|---|---|
| Owner / Operator | M.I.Tech Co., Ltd. (#10030918) |
| Address | 458, Bongeunsa-ro, Gangnam-gu, Seoul, 06154, KR |
| Mandatory US Agent | LK Consulting Group USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ESW |
| Regulation § (21 CFR) | 878.3610 |
| Proprietary names | HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN) |
Source: openFDA. Public-domain (CC0).