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510(k) Data Aggregation

    K Number
    K061737
    Device Name
    LOSS OF RESISTANCE SYRINGE
    Manufacturer
    ROBERT BUSSE & CO., INC.
    Date Cleared
    2006-12-18

    (181 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ROBERT BUSSE **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Busse Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
    Device Description
    The Busse Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.
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