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510(k) Data Aggregation

    K Number
    K003063
    Date Cleared
    2000-11-22

    (51 days)

    Product Code
    Regulation Number
    878.4460
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIMBEL GLOVE CO., LLC.

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