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510(k) Data Aggregation

    K Number
    K043118
    Device Name
    HYDROGUM SOFT
    Manufacturer
    Date Cleared
    2005-01-24

    (75 days)

    Product Code
    Regulation Number
    872.3660
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROGUM SOFT

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