FDA Device Establishments · JSON-LD · Markdown
FEI 3010132318 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3010132318 |
|---|---|
| Owner / Operator | Polarean, Inc. (#10087679) |
| Address | 2500 Meridian Pkwy, #175, Durham, NC, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MOS |
| Regulation § (21 CFR) | 892.1000 |
| Proprietary names | XENOVIEW 3T Chest Coil |
Source: openFDA. Public-domain (CC0).