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

    BARD ELIMINATOR PET BALLOON DILATORS

    K Number: K033936 · Decision Jan 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    645
    Review Days
    26

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    Basic Information

    Device Name
    BARD ELIMINATOR PET BALLOON DILATORS
    K Number
    K033936
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 19, 2003
    Decision Date
    January 14, 2004
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

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