BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HANAROSTENT® Esophageal TTS (CCC)

    Reg #: 3011458193 · FEI: 3011458193 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    M.I.Tech Co., Ltd.
    Registration Number
    3011458193
    FEI Number
    3011458193
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    458, Bongeunsa-ro, Gangnam-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200860

    Owner / Operator

    Firm Name
    M.I.Tech Co., Ltd.
    Operator Number
    10030918
    Address
    174, habuk 2gil, jinwimyeon
    City
    Pyeongtaek
    State
    Gyeonggi
    Postal Code
    17706
    Country
    KR
    Correspondent
    Inae Kim

    US Agent

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

    Products

    Device Name Product Code
    Prosthesis, Esophageal ESW

    Proprietary Names

    HANAROSTENT® Esophageal TTS (CCC) HANAROSTENT® Esophageal TTS (NCN)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility