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

    MODIFIED MEMORY RETRACTOR ARM

    K Number: K895537 · Decision Sep 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    10

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    Basic Information

    Device Name
    MODIFIED MEMORY RETRACTOR ARM
    K Number
    K895537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medical Equipment Development Co., Inc.
    Date Received
    September 12, 1989
    Decision Date
    September 22, 1989
    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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