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510(k) Data Aggregation

    K Number
    K052169
    Device Name
    IMC SURGICAL DRAPES
    Manufacturer
    INTERNATIONAL MEDSURG CONNECTION, INC.
    Date Cleared
    2005-11-17

    (100 days)

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

    INTERNATIONAL MEDSURG CONNECTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
    Device Description
    Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.
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    K Number
    K042893
    Device Name
    UNDER BUTTOCKS DRAPE
    Manufacturer
    INTERNATIONAL MEDSURG CONNECTION, INC.
    Date Cleared
    2005-03-11

    (143 days)

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

    INTERNATIONAL MEDSURG CONNECTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).
    Device Description
    The International Medsurg Connection Fluid Collection Under Buttocks Drape.
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