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

    SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M

    K Number: K910783 · Decision Apr 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
    K Number
    K910783
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew Equipment Group
    Date Received
    February 25, 1991
    Decision Date
    April 2, 1991
    Product Code
    BWN
    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
    BWN Table And Attachments, Operating-Room

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