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

    ETB TROCAR SYSTEM

    K Number: K990894 · Decision May 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    ETB TROCAR SYSTEM
    K Number
    K990894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Altomec Corp.
    Date Received
    March 18, 1999
    Decision Date
    May 19, 1999
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by The Altomec Corp.

    K Number Device Name
    K972298 ETB TELESCOPE W/WORKING CHANNEL FOR SEPS