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

    GREINER VACUETTE QUICKSHIELD COMPLETE

    K Number: K072320 · Decision Sep 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    10
    Review Days
    25

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    Basic Information

    Device Name
    GREINER VACUETTE QUICKSHIELD COMPLETE
    K Number
    K072320
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greiner Bio-One North America, Inc.
    Date Received
    August 20, 2007
    Decision Date
    September 14, 2007
    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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