BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)

    K Number: K000388 · Decision Aug 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
    K Number
    K000388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearwater Colon Hydrotherapy, Inc.
    Date Received
    February 7, 2000
    Decision Date
    August 8, 2000
    Product Code
    KPL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPL Colonic Irrigation System

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    Other Clearances by Clearwater Colon Hydrotherapy, Inc.

    K Number Device Name
    K942867 CLEARWATER COLON HYDROTHERAPY MODEL PPC-101