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

    CANCEL

    K Number: K812582 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    100
    Applicant Total
    2
    Review Days
    13

    Basic Information

    Device Name
    CANCEL
    K Number
    K812582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    BIO SYSTEMS, INC.
    Date Received
    September 10, 1981
    Decision Date
    September 23, 1981
    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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