BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098

    K Number: K062653 · Decision Oct 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
    K Number
    K062653
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Parnell Pharmaceuticals, Inc.
    Date Received
    September 7, 2006
    Decision Date
    October 27, 2006
    Product Code
    LFD
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFD Saliva, Artificial

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