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510(k) Data Aggregation

    K Number
    K003659
    Date Cleared
    2001-02-20

    (84 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260

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