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

    SUCTION INSTRUMENTATION

    K Number: K972074 · Decision Jul 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    56
    Review Days
    52

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    Basic Information

    Device Name
    SUCTION INSTRUMENTATION
    K Number
    K972074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Walter Lorenz Surgical, Inc.
    Date Received
    June 3, 1997
    Decision Date
    July 25, 1997
    Product Code
    GCX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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