BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AIIFIM Implant System

    Reg #: 3005115116 · FEI: 3005115116 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COWELLMEDI CO., LTD.
    Registration Number
    3005115116
    FEI Number
    3005115116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    48, Hakgam-daero 221beon-gil, Sasang-Gu
    City
    BUSAN
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K050635

    Owner / Operator

    Firm Name
    COWELLMEDI CO., LTD.
    Operator Number
    9071264
    Address
    48, Hakgam-Daero 221beon-Gil, Sasang-Gu
    City
    Busan
    State
    KR-NOTA
    Postal Code
    46986
    Country
    KR
    Correspondent
    MINJIN PARK

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman STE 160, Irvine CA 92612
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    AIIFIM Implant System

    Establishment Types

    Manufacture Medical Device