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

    OSTOMY OR UROSTOMY ABDOMINAL BELT OS

    K Number: K842119 · Decision Sep 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    100
    Applicant Total
    1
    Review Days
    110

    Basic Information

    Device Name
    OSTOMY OR UROSTOMY ABDOMINAL BELT OS
    K Number
    K842119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    ATLAS SURGICAL BELT CO., INC.
    Date Received
    May 23, 1984
    Decision Date
    September 10, 1984
    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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