BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    VASSALLO GT 018 Floppy

    Reg #: 3012223769 · FEI: 3008411636 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FILMECC CO., LTD.
    Registration Number
    3012223769
    FEI Number
    3008411636
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-99 Akatsuki-cho
    City
    Seto-shi Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K213949

    Owner / Operator

    Firm Name
    Filmecc Co., Ltd.
    Operator Number
    10075566
    Address
    3-99 Akatsuki-cho,
    City
    Seto-shi,
    State
    Aichi
    Postal Code
    489-0071
    Country
    JP

    US Agent

    Business Name
    FILMECC USA, INC.
    Contact Name
    Takashi Kawasaki
    Address
    3002 Dow Ave Suite 216
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    949 7568252

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    VASSALLO GT 018 Floppy

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198