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510(k) Data Aggregation

    K Number
    K083424
    Device Name
    BUSSE SURGICAL DRAPE
    Manufacturer
    BUSSE HOSIPITAL DISPOSABLES
    Date Cleared
    2009-02-26

    (99 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BUSSE HOSIPITAL DISPOSABLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. There are various models of drapes: Non-woven drapes, Tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.
    Device Description
    Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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    K Number
    K080804
    Device Name
    BUSSE PLASTIC LOR SYRINGE
    Manufacturer
    BUSSE HOSIPITAL DISPOSABLES
    Date Cleared
    2008-07-09

    (110 days)

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

    BUSSE HOSIPITAL DISPOSABLES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Busse Plastic LOR 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 Busse Plastic LOR 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 LOR plastic 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.
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