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510(k) Data Aggregation

    K Number
    K051344
    Device Name
    COLONIC AND ENEMA NOZZLE
    Manufacturer
    ULTIMATE CONCEPTS, INC.
    Date Cleared
    2005-08-18

    (87 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTIMATE CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
    Device Description
    This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.
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    K Number
    K033149
    Device Name
    ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
    Manufacturer
    ULTIMATE CONCEPTS, INC.
    Date Cleared
    2004-03-23

    (175 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTIMATE CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
    Device Description
    This colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the temperature, and gravity induced flow of water through the nozzle to be controlled. The device includes a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. This device uses water that comes from household type hot and cold outlets.
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