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

    MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

    K Number: K030443 · Decision May 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
    K Number
    K030443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nastech Pharmaceutical Company, Inc.
    Date Received
    February 11, 2003
    Decision Date
    May 9, 2003
    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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    Other Clearances by Nastech Pharmaceutical Company, Inc.

    K Number Device Name
    K012088 NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT