BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Levo System

    Reg #: 3020981894 · FEI: 3020981894 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STARFISH PRODUCT ENGINEERING
    Registration Number
    3020981894
    FEI Number
    3020981894
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    139 Mulock Ave
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K140845

    Owner / Operator

    Firm Name
    StarFish Product Engineering
    Operator Number
    10083441
    Address
    139 Mulock Ave
    City
    Toronto
    State
    Ontario
    Postal Code
    M6N 1G9
    Country
    CA

    US Agent

    Business Name
    StarFish Medical
    Contact Name
    Kathryn Kukulka
    Address
    15560 Rockfield Blvd Ste D
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 4720275

    Products

    Device Name Product Code
    Masker, Tinnitus KLW

    Proprietary Names

    Levo System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)