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

    MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM

    K Number: K990515 · Decision May 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
    K Number
    K990515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Medical Systems
    Date Received
    February 18, 1999
    Decision Date
    May 13, 1999
    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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    K Number Device Name
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