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510(k) Data Aggregation

    K Number
    K122358
    Device Name
    NOVEON
    Date Cleared
    2014-03-11

    (585 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOGAN LOVELLS US, L.L.P.

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