BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WILSON-COOK LUNG BIOPSY NEEDLE

    K Number: K897050 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    125
    Review Days
    119

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    Basic Information

    Device Name
    WILSON-COOK LUNG BIOPSY NEEDLE
    K Number
    K897050
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    December 18, 1989
    Decision Date
    April 16, 1990
    Product Code
    GAA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAA Needle, Aspiration And Injection, Disposable

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