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    K Number
    K093473
    Device Name
    KMD-MARK1 TISSUE MARKER
    Manufacturer
    KENT MEDICAL DEVICES, INC.
    Date Cleared
    2010-07-02

    (238 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENT MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
    Device Description
    KMD-Markl Tissue Marker is a sterile, single patient use, polymeric discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). KMD-Mark1 Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
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