BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hawkins II Breast Localization Needle w/ Hardware

    Reg #: 1625425 · FEI: 1625425 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ARGON MEDICAL DEVICES INC.
    Registration Number
    1625425
    FEI Number
    1625425
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1445 FLAT CREEK RD.
    City
    ATHENS
    State
    TX
    ZIP
    75751
    Country
    US

    Regulatory Submissions

    510(k) Number
    K870523

    Owner / Operator

    Firm Name
    ARGON MEDICAL DEVICES, INC
    Operator Number
    9059795
    Address
    1445 FLAT CREEK ROAD, --
    City
    Athens
    State
    TX
    Postal Code
    75751
    Country
    US
    Correspondent
    Scott Bishop

    Products

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

    Proprietary Names

    Hawkins II Breast Localization Needle w/ Hardware Hawkins III Breas Localization Needle w/ Flexstrand Hawkins III Breast Localization Needle w/ Echogenic Tip and Hardwire Hawkins I Breast Localization Needles Hawkins III Breast Localization Needle w/ Hardware Hawkins II Breast Localization Needles w/ Flexstrand

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)