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

    DOVER ROB-NEL CATHETER

    K Number: K040897 · Decision Jul 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    236
    Applicant Total
    14
    Review Days
    105

    Basic Information

    Device Name
    DOVER ROB-NEL CATHETER
    K Number
    K040897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TYCO HEALTHCARE
    Date Received
    April 6, 2004
    Decision Date
    July 20, 2004
    Product Code
    KOD
    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
    KOD Catheter, Urological

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