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

    PREMIE U-BAG URINE SPECIMEN COLLECTOR

    K Number: K950176 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    85
    Review Days
    21

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    Basic Information

    Device Name
    PREMIE U-BAG URINE SPECIMEN COLLECTOR
    K Number
    K950176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hollister, Inc.
    Date Received
    January 17, 1995
    Decision Date
    February 7, 1995
    Product Code
    FOC
    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
    FOC Bag, Urine Collection, Newborn

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