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510(k) Data Aggregation

    K Number
    K101709
    Device Name
    LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
    Manufacturer
    STEVEN B. LAMBERG, DDS
    Date Cleared
    2010-08-18

    (62 days)

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

    STEVEN B. LAMBERG, DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the reduction of night-time snoring or mild to moderate obstructive sleep apnea in adults 18 years of age or older. Prescription use only. The LambergSleepWell-Smartrusion is used to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The LSW-S is a removable intraoral device consisting of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth by means of a protrusive element on the upper member relating to the protrusive element's mate on the lower member. This interface, and thus this device, productions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. Every device is pharying a open your of reach patient and is adjustable at the time of delivery and anytime thereafter.
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