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510(k) Data Aggregation

    K Number
    K062951
    Device Name
    TAP III ANTI-SNORING DEVICE
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Date Cleared
    2006-12-12

    (74 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRWAY MANAGEMENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
    Device Description
    The TAP III Anti-Snoring device is comprised of: - Lower tray fitted over the lower teeth. - Upper tray fitted over the upper teeth. - Impression material - Hook and Base mechanism to attach lower tray to upper tray.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRWAY MANAGEMENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K060388
    Device Name
    TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Date Cleared
    2006-05-17

    (92 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRWAY MANAGEMENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
    Device Description
    The TAP II Anti-Snoring device is comprised of: - & Lower tray fitted over the lower teeth. - Upper tray fitted over the upper teeth. - Impression material - Hook and Base mechanism to attach lower tray to upper tray.
    Ask a Question

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