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510(k) Data Aggregation

    K Number
    K152834
    Device Name
    Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
    Manufacturer
    COLONPLUS EQUIPMENTS & SPECULUMS, S.L.
    Date Cleared
    2016-08-10

    (316 days)

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

    **COLONPLUS EQUIPMENTS **& SPECULUMS, S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
    Device Description
    The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
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