BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Sodium Chloride Inj. 0.9% USP 5mL and 10mL Ampule

    Reg #: 3007163376 · FEI: 3007163376 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HUONS CO., LTD.
    Registration Number
    3007163376
    FEI Number
    3007163376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100, Bio Valley-ro
    City
    Jecheon-si Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K103740

    Owner / Operator

    Firm Name
    HUONS CO., LTD.
    Operator Number
    10026948
    Address
    200 Spectrum Center Dr., Unit 4036
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    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
    Saline, Vascular Access Flush NGT

    Proprietary Names

    Sodium Chloride Inj. 0.9% USP 5mL and 10mL Ampule

    Establishment Types

    Manufacture Medical Device