BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SurgiTel

    Reg #: 1834177 · FEI: 1000160378 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENERAL SCIENTIFIC CORP.
    Registration Number
    1834177
    FEI Number
    1000160378
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    77 ENTERPRISE DR.
    City
    ANN ARBOR
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K934494

    Owner / Operator

    Firm Name
    General Scientific Corporation
    Operator Number
    9009191
    Address
    77 Enterprise Dr, --
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Carrie A Good

    Products

    Device Name Product Code
    Spectacle, Operating (Loupe), Ophthalmic HOH

    Proprietary Names

    SurgiTel

    Establishment Types

    Manufacture Medical Device