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510(k) Data Aggregation

    K Number
    K094022
    Device Name
    THE WATER LILY
    Manufacturer
    CLEARWATER PRODUCTS, LLC
    Date Cleared
    2010-06-11

    (163 days)

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

    CLEARWATER PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).
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