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

    CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE

    K Number: K862481 · Decision Jul 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    29
    Review Days
    23

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    Basic Information

    Device Name
    CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
    K Number
    K862481
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    CIVCO Medical Instruments Co., Inc.
    Date Received
    June 30, 1986
    Decision Date
    July 23, 1986
    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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