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510(k) Data Aggregation

    K Number
    K001287
    Date Cleared
    2000-06-09

    (46 days)

    Product Code
    Regulation Number
    880.5025
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

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