FDA Device Establishments · JSON-LD · Markdown
FEI 3027395815 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3027395815 |
|---|---|
| Owner / Operator | Summa Therapeutics, LLC (#10088115) |
| Address | 119 Braintree St Ste 508, Allston, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LIT |
| Regulation § (21 CFR) | 870.1250 |
| Proprietary names | Finesse Injectable PTA Balloon Dilatation Catheter |
Source: openFDA. Public-domain (CC0).