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

    URINARY DRAINAGE BAG

    K Number: K951597 · Decision Aug 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    URINARY DRAINAGE BAG
    K Number
    K951597
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Key Medical Services, Inc.
    Date Received
    April 7, 1995
    Decision Date
    August 4, 1995
    Product Code
    EYZ
    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
    EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

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    Other Clearances by Key Medical Services, Inc.

    K Number Device Name
    K934142 URINARY DRAINAGE BAG