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510(k) Data Aggregation

    K Number
    K071057
    Device Name
    COLONIC & ENEMA NOZZLE
    Manufacturer
    TILLER MIND BODY, INC.
    Date Cleared
    2007-10-05

    (172 days)

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

    TILLER MIND BODY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
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    K Number
    K962259
    Device Name
    LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
    Manufacturer
    TILLER MIND BODY, INC.
    Date Cleared
    1996-08-29

    (78 days)

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

    TILLER MIND BODY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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