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510(k) Data Aggregation

    K Number
    K080516
    Device Name
    LAMIN AIR
    Manufacturer
    REMGENIC LLC
    Date Cleared
    2008-06-23

    (119 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMGENIC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use
    Device Description
    The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. - . Three (3) sizes of nasal inserts to assure a good fit - . Integral fixed leak port - . Headgear for attachment
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