BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fusion Classic

    Reg #: 3005598536 · FEI: 3005598536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SOMNOMED INC.
    Registration Number
    3005598536
    FEI Number
    3005598536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6513 Windcrest Dr Ste 100
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140278

    Owner / Operator

    Firm Name
    SOMNOMED INC.
    Operator Number
    9071127
    Address
    6513 Windcrest Drive, Suite #100
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Mary Kennell

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK

    Proprietary Names

    Fusion Classic Fusion Flex

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device