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510(k) Data Aggregation

    K Number
    K011588
    Device Name
    SURETONE
    Manufacturer
    SURETONE INTERNATIONAL
    Date Cleared
    2002-03-28

    (309 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURETONE INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.
    Device Description
    The "Surestim" is an electrical powered muscle stimulator.
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