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510(k) Data Aggregation

    K Number
    K131852
    Device Name
    HC-1 AND HC-1 CLASSIC
    Manufacturer
    TRANSCENDENCIAS COMERCIALES SL TRANSCOM
    Date Cleared
    2014-04-17

    (300 days)

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

    TRANSCENDENCIAS COMERCIALES SL TRANSCOM

    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 HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy. The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.
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