BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CorneaGen

    Reg #: 3005357288 · FEI: 3005357288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CorneaGen
    Registration Number
    3005357288
    FEI Number
    3005357288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    101 N Chestnut St Ste 303
    City
    Winston Salem
    State
    NC
    ZIP
    27101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090626

    Owner / Operator

    Firm Name
    CorneaGen
    Operator Number
    10046718
    Address
    101 N Chestnut St, Suite 303
    City
    Winston Salem
    State
    NC
    Postal Code
    27101
    Country
    US
    Correspondent
    Nora Brown

    Products

    Device Name Product Code
    Graft Insertion Instrument For Endothelial Keratoplasty OTZ

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device