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510(k) Data Aggregation

    K Number
    K970130
    Manufacturer
    Date Cleared
    1997-03-28

    (72 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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