BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SleepRight

    Reg #: 3003460151 · FEI: 3003322666 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Splintek Inc.
    Registration Number
    3003460151
    FEI Number
    3003322666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15555 W 108th Street
    City
    Lenexa
    State
    KS
    ZIP
    66219
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071404

    Owner / Operator

    Firm Name
    Splintek Inc.
    Operator Number
    9047750
    Address
    15555 W 108th Street, --
    City
    Lenexa
    State
    KS
    Postal Code
    66219
    Country
    US
    Correspondent
    Thomas - Brown

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Mouthguard, Over-The-Counter OBR

    Proprietary Names

    SleepRight

    Establishment Types

    Manufacture Medical Device