BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medley Gold

    Reg #: 1316408 · FEI: 1316408 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Great Lakes Dental Technologies, Ltd.
    Registration Number
    1316408
    FEI Number
    1316408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 COOPER AVENUE
    City
    TONAWANDA
    State
    NY
    ZIP
    14150
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140435

    Owner / Operator

    Firm Name
    Great Lakes Dental Technologies, Ltd.
    Operator Number
    1316408
    Address
    200 COOPER AVE., --
    City
    Tonawanda
    State
    NY
    Postal Code
    14150
    Country
    US
    Correspondent
    Joseph Mazurkiewicz

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK

    Proprietary Names

    Medley Gold

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)