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510(k) Data Aggregation

    K Number
    K990515
    Device Name
    MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
    Manufacturer
    INTERNATIONAL MEDICAL SYSTEMS
    Date Cleared
    1999-05-13

    (84 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
    Device Description
    The Mathis Vertebral and Bone Biopsy System is a standard bone marrow biopsy needle consisting of a cannula with a sharpened distal end and a stylet received coaxially in the cannula and having a sharpened distal end protruding from the distal end of the cannula. The cannula is insert molded to a hub with standard threadable lug tabs. The stylet is insert molded to a standard hub. When the stylet assembly is placed into the cannula assembly, the entire cannula/stylet unit can be threaded into a removable gripable handle.
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