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

    LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER

    K Number: K053321 · Decision Jan 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
    K Number
    K053321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xodus Medical, Inc.
    Date Received
    November 30, 2005
    Decision Date
    January 19, 2006
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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