BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FOURTE Expander Fill System

    Reg #: 9681387 · FEI: 3002808401 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TSK Laboratory International Japan KK
    Registration Number
    9681387
    FEI Number
    3002808401
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Chome 1-5, Hirayanagi-Machi
    City
    Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K161483

    Owner / Operator

    Firm Name
    TSK Laboratory, International Japan
    Operator Number
    10083590
    Address
    2-1-5 Hirayanagi-Cho
    City
    Tochigi
    State
    JP-09
    Postal Code
    328-0012
    Country
    JP
    Correspondent
    Norman S Johnson

    US Agent

    Business Name
    Johnson Global California LLC
    Contact Name
    Norman Johnson
    Address
    2151 Michelson Dr Ste 135
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 7140294

    Products

    Device Name Product Code
    Tissue Expander And Accessories LCJ

    Proprietary Names

    FOURTE Expander Fill System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device