FDA Device Establishments · JSON-LD · Markdown
FEI 3006007013 · Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3006007013 |
|---|---|
| Owner / Operator | PARK-ISTRE, LLC. (#9093900) |
| Address | 4001 McEwen Rd, STE. 408, DALLAS, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | ELZ |
| Regulation § (21 CFR) | 872.3330 |
| Proprietary names | Acero Narrow NA Crowns; Acero NS; Acero ES Crowns; Acero XT Crowns; Acero 3S Crowns; Acero ESL Crowns; Acero Z1 Crowns |
Source: openFDA. Public-domain (CC0).