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510(k) Data Aggregation

    K Number
    DEN040009
    Date Cleared
    2004-11-04

    (71 days)

    Product Code
    Regulation Number
    884.6200
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)

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