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510(k) Data Aggregation

    K Number
    K111737
    Device Name
    DISPOSABLE ELECTRODE
    Manufacturer
    Date Cleared
    2011-10-14

    (115 days)

    Product Code
    Regulation Number
    882.1320
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    Applicant Name (Manufacturer) :

    SANIBEL SUPPLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable adhesive electrode for standard neurophysiological examinations
    Device Description
    Disposable Electrode
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