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510(k) Data Aggregation

    K Number
    K972745
    Device Name
    TITANIUM HEMOSTATIC CLIP
    Manufacturer
    EISNER USA, INC.
    Date Cleared
    1997-10-21

    (90 days)

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

    EISNER USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The Clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.
    Device Description
    The clips are composed exclusively of titanium and are supplied sterile in various sizes (small, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I.
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