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

    RECTAL TUBE DEVICE

    K Number: K760886 · Decision Dec 9, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    101
    Applicant Total
    1
    Review Days
    48

    Basic Information

    Device Name
    RECTAL TUBE DEVICE
    K Number
    K760886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Van Sickle Plastics Co.
    Date Received
    October 22, 1976
    Decision Date
    December 9, 1976
    Product Code
    EXB
    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
    EXB Collector, Ostomy

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