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

    SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

    K Number: K090272 · Decision Mar 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    26
    Review Days
    42

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    Basic Information

    Device Name
    SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
    K Number
    K090272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Inc.
    Date Received
    February 4, 2009
    Decision Date
    March 18, 2009
    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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