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510(k) Data Aggregation

    K Number
    K080298
    Device Name
    DERMABIOSAFE
    Manufacturer
    COMPLETE PRODUCT RESOURCES
    Date Cleared
    2008-08-05

    (182 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPLETE PRODUCT RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation).
    Device Description
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