BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FC-78

    Reg #: 3025599428 · FEI: 3025599428 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SANKO ELECTRONICS CORPORATION
    Registration Number
    3025599428
    FEI Number
    3025599428
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1500 Omama, Omama,
    City
    Midori Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K173905

    Owner / Operator

    Firm Name
    Sanko Electronics Corporation
    Operator Number
    10086958
    Address
    1500 Omama, Omama,
    City
    Midori
    State
    Gunma
    Postal Code
    376-0101
    Country
    JP
    Correspondent
    Satoru Ikeda

    US Agent

    Business Name
    NSK America Corporation
    Contact Name
    Sean Kaufman
    Address
    Office, 1800 Global Parkway Hoffman Estates
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US
    Email
    [email protected]
    Phone
    888 6751675

    Products

    Device Name Product Code
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    FC-78 Surgic Pro+ OPT(120V) Surgic Pro OPT(230V) Surgic Pro OPT(120V) Surgic Pro NON-OPT(120V)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)