FDA Device Establishments · JSON-LD · Markdown
FEI 3042969838 · Manufacture Medical Device · Status: Active
| FEI Number | 3042969838 |
|---|---|
| Owner / Operator | Shinsaegi Medi-Tech Co., Ltd. (#10094652) |
| Address | 119 Ijisandan-ro, Juchon-myeon, Gimhae-si Gyeongnam, 50968, KR |
| Mandatory US Agent | LK Consulting Group USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NDP |
| Regulation § (21 CFR) | 872.3980 |
| Proprietary names | Guide Drill (SST, SRT, IT) |
Source: openFDA. Public-domain (CC0).