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510(k) Data Aggregation

    K Number
    K014300
    Device Name
    SAFETOUCH
    Manufacturer
    JAMES D RUSIN MD, MBA
    Date Cleared
    2002-03-01

    (60 days)

    Product Code
    NHM
    Regulation Number
    884.2990
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAMES D RUSIN MD, MBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.
    Device Description
    Thin plastic film with a preprinted numbered grid and orientation markings
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