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

    INSTRUMED RETRACTORS

    K Number: K071771 · Decision Aug 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    INSTRUMED RETRACTORS
    K Number
    K071771
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumed International, Inc.
    Date Received
    June 29, 2007
    Decision Date
    August 2, 2007
    Product Code
    GZT
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZT Retractor, Self-Retaining, For Neurosurgery

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