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

    IO-TOME DEVICE

    K Number: K113073 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    10
    Review Days
    284

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    Basic Information

    Device Name
    IO-TOME DEVICE
    K Number
    K113073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxano, Inc.
    Date Received
    October 17, 2011
    Decision Date
    July 27, 2012
    Product Code
    HAE
    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
    HAE Rongeur, Manual

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