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510(k) Data Aggregation

    K Number
    K991926
    Device Name
    OPAP
    Manufacturer
    OPAP, INC.
    Date Cleared
    1999-10-18

    (133 days)

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

    OPAP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OPAP ® device is an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea. This device is indicated for use with CPAP and Bilevel systems. The OPAP Of facilitated delivery of or CPAP and Bilevel is similar to nasal mask CPAP and Bilevel. Individual patients and specific problems may or may not be treated more effectively with the OPAP C. Consult your sleep physician or dentist.
    Device Description
    an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea.
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