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

    NEUROTUBE

    K Number: K983007 · Decision Mar 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    206

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    Basic Information

    Device Name
    NEUROTUBE
    K Number
    K983007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuroregen, LLC
    Date Received
    August 28, 1998
    Decision Date
    March 22, 1999
    Product Code
    JXI
    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
    JXI Cuff, Nerve

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