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510(k) Data Aggregation

    K Number
    K002102
    Device Name
    GENTLE COLONICS IRRIGATION SYSTEM
    Manufacturer
    GENTLE COLONICS, INC.
    Date Cleared
    2002-02-06

    (574 days)

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

    GENTLE COLONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980868
    Device Name
    GC IRRIGATOR
    Manufacturer
    GENTLE COLONICS, INC.
    Date Cleared
    1998-08-06

    (153 days)

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

    GENTLE COLONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GC Irrigator is intended for use for colon cleansing when medically indicated, such as before radiological or endoscopic examination. To be used with commercially available gravity flow colonic irrigation units.
    Device Description
    GC Irrigator
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