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

    MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE

    K Number: K983187 · Decision Dec 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
    K Number
    K983187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medsol Corp.
    Date Received
    September 11, 1998
    Decision Date
    December 10, 1998
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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