BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Breast Localization Needle

    Reg #: 1828424 · FEI: 1828424 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    HART ENTERPRISES, INC.
    Registration Number
    1828424
    FEI Number
    1828424
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 APPLEJACK CT.
    City
    SPARTA
    State
    MI
    ZIP
    49345
    Country
    US

    Regulatory Submissions

    510(k) Number
    K881730

    Owner / Operator

    Firm Name
    HART ENTERPRISES, INC.
    Operator Number
    1828424
    Address
    400 APPLEJACK CT., --
    City
    Sparta
    State
    MI
    Postal Code
    49345
    Country
    US
    Correspondent
    ROBERT L STRIEBEL

    Products

    Device Name Product Code
    Needle, Aspiration And Injection, Reusable GDM

    Proprietary Names

    Breast Localization Needle

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device