BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Occluder Balloon

    Reg #: 3008254127 · FEI: 3008254127 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    THE O R COMPANY PTY LTD
    Registration Number
    3008254127
    FEI Number
    3008254127
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4/47 Wangara Road
    City
    Cheltenham Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K220202

    Owner / Operator

    Firm Name
    The O R Company Pty Ltd
    Operator Number
    10031641
    Address
    4/47 Wangara Road
    City
    Cheltenham
    State
    Victoria
    Postal Code
    3192
    Country
    AU
    Correspondent
    Justin Abraham

    US Agent

    Business Name
    ASPEN SURGICAL PRODUCTS, INC.
    Contact Name
    Chris Smith
    Address
    6945 SOUTHBELT DR. S.E.
    City
    Caledonia
    State
    MI
    ZIP
    49316
    Country
    US
    Email
    [email protected]
    Phone
    615 9645392

    Products

    Device Name Product Code
    Cannula, Manipulator/Injector, Uterine LKF

    Proprietary Names

    Occluder Balloon

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor