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

    SKYTRON ELITE SURGICAL TABLES

    K Number: K811311 · Decision Jun 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    19
    Review Days
    22

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    Basic Information

    Device Name
    SKYTRON ELITE SURGICAL TABLES
    K Number
    K811311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Skytron, Div. the Kmw Group, Inc.
    Date Received
    May 11, 1981
    Decision Date
    June 2, 1981
    Product Code
    GBC
    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
    GBC Lamp, Surgical, Incandescent

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