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510(k) Data Aggregation

    K Number
    K070344
    Device Name
    LIV BREAST SELF EXAMINATION AID
    Date Cleared
    2007-03-08

    (30 days)

    Product Code
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIV INTERNATIONAL USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.
    Device Description
    The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations. The device is made of soft, latex-free polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
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