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510(k) Data Aggregation

    K Number
    K091598
    Manufacturer
    Date Cleared
    2009-06-29

    (26 days)

    Product Code
    Regulation Number
    892.5700
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS

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