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    K Number
    K980363
    Device Name
    ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
    Manufacturer
    OROFACIAL DYNAMICS
    Date Cleared
    1998-04-16

    (77 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    OROFACIAL DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.
    Device Description
    The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.
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