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

    TROCAR DISPOSABLE

    K Number: K904638 · Decision Feb 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    8
    Applicant Total
    14
    Review Days
    133

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    Basic Information

    Device Name
    TROCAR DISPOSABLE
    K Number
    K904638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    L.A.S.E.R., Inc.
    Date Received
    October 11, 1990
    Decision Date
    February 21, 1991
    Product Code
    FBQ
    Advisory Committee
    Gastroenterology, Urology
    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
    FBQ Trocar, Gastro-Urology

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