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

    RENTON SUCTION DEVICE U.S. PATENT*4,767,404

    K Number: K962920 · Decision Oct 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    RENTON SUCTION DEVICE U.S. PATENT*4,767,404
    K Number
    K962920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R&S Surgical, LLC
    Date Received
    July 26, 1996
    Decision Date
    October 21, 1996
    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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