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510(k) Data Aggregation

    K Number
    K980171
    Device Name
    DERMASENSE PLUS DISPERSIVE ELECTRODE
    Date Cleared
    1998-02-27

    (38 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HORIZON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.
    Device Description
    DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.
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