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510(k) Data Aggregation

    K Number
    K061732
    Device Name
    TAP-T
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Date Cleared
    2006-07-12

    (22 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K962516,K972061,K060388
    Why did this record match?
    Device Name :

    TAP-T

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

    Device Description

    The TAP T Anti -- snoring device is comprised of -- - 트 Lower tray fitted over the lower teeth. - . Upper tray fitted over the upper teeth. - 트 Impression material - . Hook mechanism to attach to lower tray to upper tray

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) premarket notification summary for the TAP T device, outlining its description, intended use, and substantial equivalence to predicate devices, but it does not contain details of any performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information.

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