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

    HEAD FIXATION ARC AND TABLE BASE

    K Number: K091439 · Decision Aug 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    4
    Review Days
    103

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    Basic Information

    Device Name
    HEAD FIXATION ARC AND TABLE BASE
    K Number
    K091439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgivision, Inc.
    Date Received
    May 14, 2009
    Decision Date
    August 25, 2009
    Product Code
    HBL
    Advisory Committee
    Neurology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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