BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE

    K Number: K843690 · Decision Oct 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    8
    Review Days
    36

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    Basic Information

    Device Name
    ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
    K Number
    K843690
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Popper & Sons, Inc.
    Date Received
    September 19, 1984
    Decision Date
    October 25, 1984
    Product Code
    GDM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDM Needle, Aspiration And Injection, Reusable

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