FDA Device Establishments · JSON-LD · Markdown
FEI 3014409527 · Manufacture Medical Device · Status: Active
| FEI Number | 3014409527 |
|---|---|
| Owner / Operator | InTheSmart Co., Ltd. (#10057252) |
| Address | Center for Medical Innovation (CMI) Bld. 71 DAEHAK-RO, JONGRO-GU Seoul, 03082, KR |
| Mandatory US Agent | OPTOSURGICAL LLC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FCQ |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | ITSEL1711 |
Source: openFDA. Public-domain (CC0).