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

    LEVY ARTICULATING RETRACTOR

    K Number: K920471 · Decision Jun 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    12
    Review Days
    147

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    Basic Information

    Device Name
    LEVY ARTICULATING RETRACTOR
    K Number
    K920471
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lifeguard Medical Products, Inc.
    Date Received
    January 28, 1992
    Decision Date
    June 23, 1992
    Product Code
    GAD
    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
    GAD Retractor

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