BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Splashield

    Reg #: 2084203 · FEI: 2084203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZEROWET, INC.
    Registration Number
    2084203
    FEI Number
    2084203
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333 Fuller Ave NE
    City
    Grand Rapids
    State
    MI
    ZIP
    49503
    Country
    US

    Regulatory Submissions

    510(k) Number
    K900208

    Owner / Operator

    Firm Name
    Zerowet, Inc.
    Operator Number
    10024418
    Address
    333 Fuller Ave NE
    City
    Grand Rapids
    State
    MI
    Postal Code
    49503
    Country
    US
    Correspondent
    Joel Marogil

    Products

    Device Name Product Code
    Syringe, Irrigating (Non Dental) KYZ

    Proprietary Names

    Splashield Supershield Klenzalac Zerowet

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility