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

    GLASSMAN STONE EXTRACTION SET

    K Number: K904472 · Decision Dec 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    37
    Applicant Total
    125
    Review Days
    88

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    Basic Information

    Device Name
    GLASSMAN STONE EXTRACTION SET
    K Number
    K904472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    October 1, 1990
    Decision Date
    December 28, 1990
    Product Code
    LQR
    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
    LQR Dislodger, Stone, Biliary

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