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

    DAUM BONE BIOPSY SET

    K Number: K981320 · Decision Jun 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    6
    Review Days
    80

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    Basic Information

    Device Name
    DAUM BONE BIOPSY SET
    K Number
    K981320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Daum Corp.
    Date Received
    April 10, 1998
    Decision Date
    June 29, 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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    K974576 DAUM BIOPSYGUN
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