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

    MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE

    K Number: K043397 · Decision Dec 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    190
    Review Days
    19

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    Basic Information

    Device Name
    MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
    K Number
    K043397
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson & CO
    Date Received
    December 10, 2004
    Decision Date
    December 29, 2004
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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