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510(k) Data Aggregation

    K Number
    K180800
    Device Name
    Colonic Plus Regular, Small, and Straight Shape Hydrokit
    Manufacturer
    Colonic Plus
    Date Cleared
    2018-06-01

    (66 days)

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

    Colonic Plus

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.
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