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510(k) Data Aggregation

    K Number
    K001413
    Manufacturer
    Date Cleared
    2000-06-02

    (29 days)

    Product Code
    Regulation Number
    870.3680
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668

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