BEUDAMED
    FDA Registration Inactive 🇰🇷 South Korea

    Endoscope Leak Tester

    · Expires 2025
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHENT CO., LTD. PLANT DIVISION
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 1119~1122, 1124~1126, 63 Samwon-ro, Deogyang-gu
    City
    Goyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K020379

    Owner / Operator

    Firm Name
    SHENT Co., Ltd. Plant Division
    Operator Number
    10093604
    Address
    Room 1119~1122, 1124~1126, 63 Samwon-ro, Deogyang-gu
    City
    Goyang-si
    State
    Gyeonggi
    Postal Code
    10550
    Country
    KR
    Correspondent
    Seung Il Suh

    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
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Endoscope Leak Tester Occlusion Balloons Bite Block Disposable Grasping Forceps Washing Catheter Disposable Retrieval Bakset Biopsy Forceps Endoscope Cleaning Brush PPD Pressure Dilators

    Establishment Types

    Manufacture Medical Device