BEUDAMED
    FDA Registration Active 🇺🇸 United States

    D800

    Reg #: 1450503 · FEI: 1450503 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUMMIT INDUSTRIES, LLC
    Registration Number
    1450503
    FEI Number
    1450503
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7555 N. Caldwell Avenue
    City
    Niles
    State
    IL
    ZIP
    60714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K874687

    Owner / Operator

    Firm Name
    SUMMIT INDUSTRIES, LLC
    Operator Number
    1450503
    Address
    7555 N. Caldwell Avenue, --
    City
    Niles
    State
    IL
    Postal Code
    60714
    Country
    US
    Correspondent
    Joe Flies

    Products

    Device Name Product Code
    Collimator, Manual, Radiographic IZX

    Proprietary Names

    D800 LX125

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198