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

    DRAINAGE BAG, 4000 ML.

    K Number: K770557 · Decision Mar 24, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    42
    Review Days
    3

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    Basic Information

    Device Name
    DRAINAGE BAG, 4000 ML.
    K Number
    K770557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Concord Laboratories, Inc.
    Date Received
    March 21, 1977
    Decision Date
    March 24, 1977
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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