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    K Number
    K130504
    Device Name
    ASA ORAL APPLIANCES
    Manufacturer
    AMERICAN SLEEP ASSOCIATION
    Date Cleared
    2013-10-18

    (233 days)

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

    AMERICAN SLEEP ASSOCIATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASA Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
    Device Description
    The American Sleep Association (ASA) Oral Appliances include three devices: the ASA Herbst and Herbst/Hilsen Hybrid devices. All are removable, intraoral devices which reposition the mandible and each is custom-fabricated to individual patient specifications. The devices are comprised of thermoformed polymer splints (copolyester or EVA) which are connected bilaterally via a stainless steel telescoping Herbst mechanism, reclosable fasteners or both.
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