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510(k) Data Aggregation

    K Number
    K970360
    Device Name
    MITEK SUTURE RETROGRADER
    Manufacturer
    Date Cleared
    1997-03-10

    (38 days)

    Product Code
    Regulation Number
    888.4540
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    HWQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Retrograde suture through soft tissue
    Device Description
    The suture retrograder is used to retrograde (pass) suture through soft tissue.
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