BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tru-Core II URO Automatic Biopsy Instruments

    Reg #: 1417485 · FEI: 1417485 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARGON MEDICAL DEVICES, INC.
    Registration Number
    1417485
    FEI Number
    1417485
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    241 W Palatine Rd
    City
    WHEELING
    State
    IL
    ZIP
    60090
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982960

    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
    Instrument, Biopsy KNW

    Proprietary Names

    Tru-Core II URO Automatic Biopsy Instruments

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)