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

    BARD EAGLE INFLATION DEVICE

    K Number: K962611 · Decision Oct 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    110

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    Basic Information

    Device Name
    BARD EAGLE INFLATION DEVICE
    K Number
    K962611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ryder Intl. Corp.
    Date Received
    July 3, 1996
    Decision Date
    October 21, 1996
    Product Code
    KOE
    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
    KOE Dilator, Urethral

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