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510(k) Data Aggregation

    K Number
    K003028
    Date Cleared
    2000-11-24

    (57 days)

    Product Code
    Regulation Number
    878.5035
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

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