BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CLAYTON COLON CLEANSING KIT

    K Number: K790535 · Decision Jun 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    CLAYTON COLON CLEANSING KIT
    K Number
    K790535
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Clayton Medical Products, Inc.
    Date Received
    March 21, 1979
    Decision Date
    June 7, 1979
    Product Code
    FCE
    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
    FCE Enema Kit

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    Other Clearances by Clayton Medical Products, Inc.

    K Number Device Name
    K833860 TUCK-TITE COLON FLUID RETAINER