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

    UROGARD URINARY DRAINAGE BAG

    K Number: K771210 · Decision Jul 11, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    9
    Applicant Total
    31
    Review Days
    6

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    Basic Information

    Device Name
    UROGARD URINARY DRAINAGE BAG
    K Number
    K771210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Terumo America, Inc.
    Date Received
    July 5, 1977
    Decision Date
    July 11, 1977
    Product Code
    FCN
    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
    FCN Urinary Drainage Collection Kit, For Indwelling Catheter

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