BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Y6228 Quiet Expressions, Y4612 Sole Expression, Y6053 Quite Expressions Plus Double

    Reg #: 1217805 · FEI: 1217805 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TOMY International, Inc.
    Registration Number
    1217805
    FEI Number
    1217805
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45 Shawmut Rd
    City
    Canton
    State
    MA
    ZIP
    02021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082802

    Owner / Operator

    Firm Name
    TOMY International
    Operator Number
    9100882
    Address
    2015 Spring Road, Suite 400
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Kenneth Li

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Y6228 Quiet Expressions, Y4612 Sole Expression, Y6053 Quite Expressions Plus Double

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility