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

    LEE BONE MARROW NEEDLES

    K Number: K842106 · Decision Aug 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    LEE BONE MARROW NEEDLES
    K Number
    K842106
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Southland Instruments, Inc.
    Date Received
    May 25, 1984
    Decision Date
    August 10, 1984
    Product Code
    GAA
    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
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by Southland Instruments, Inc.

    K Number Device Name
    K852897 LEE BONE MARROW BIOPSY/ASPIRATION TRAY