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510(k) Data Aggregation

    K Number
    K022861
    Device Name
    SAFETOUCH
    Date Cleared
    2002-11-26

    (90 days)

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

    RUSIN MEDICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.
    Device Description
    SafeTouch® Breast Exam Recording Sheet
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