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

    URINE COLLECTOR & ACCESSORIES

    K Number: K945204 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    8

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    Basic Information

    Device Name
    URINE COLLECTOR & ACCESSORIES
    K Number
    K945204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nelmed Corp.
    Date Received
    October 25, 1994
    Decision Date
    November 2, 1994
    Product Code
    FAQ
    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
    FAQ Bag, Urine Collection, Leg, For External Use, Sterile

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    Other Clearances by Nelmed Corp.

    K Number Device Name
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