BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Columbia 1 Applications

    Reg #: 3008355361 · FEI: 3008355361 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HM PRODUCT SOLUTIONS, LTD.
    Registration Number
    3008355361
    FEI Number
    3008355361
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    581 S Industrial Dr
    City
    Hartland
    State
    WI
    ZIP
    53029
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161574

    Owner / Operator

    Firm Name
    HM Product Solutions, Ltd.
    Operator Number
    10044642
    Address
    581 S. Industrial Drive
    City
    Hartland
    State
    WI
    Postal Code
    53029
    Country
    US
    Correspondent
    Robert B Maynor

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Columbia 1 Applications

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)