BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SPECTRA TUOHY ULTRASONIC

    Reg #: 3010966701 · FEI: 3010966701 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CUSTOM TUBE MANUFACTURING LLC
    Registration Number
    3010966701
    FEI Number
    3010966701
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
    City
    Yangju-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K854816

    Owner / Operator

    Firm Name
    CUSTOM TUBE MANUFACTURING LLC
    Operator Number
    10046953
    Address
    38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
    City
    Yangju-si
    State
    Gyeonggi
    Postal Code
    11413
    Country
    KR

    US Agent

    Business Name
    SPECTRA MEDICAL DEVICES, LLC
    Contact Name
    Kathy Dassler
    Address
    299 BALLARDVALE STREET, SUITE 1
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US
    Email
    [email protected]
    Phone
    978 6570889 ext. 5224

    Products

    Device Name Product Code
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP

    Proprietary Names

    SPECTRA TUOHY ULTRASONIC SPECTRA CRAWFORD ULTRASONIC SPECTRA HUSTEAD ULTRASONIC EPIDURAL NEEDLE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)