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510(k) Data Aggregation

    K Number
    K983007
    Device Name
    NEUROTUBE
    Manufacturer
    NEUROREGEN, L.L.C.
    Date Cleared
    1999-03-22

    (206 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROREGEN, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurotube is intended for single use in patients with an injury to a perioheral news, in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The time in which the nerve gap is more than of equal to o min our teen and of injury of the time of exploration of failed primary repair.
    Device Description
    The Neurotube is a woven, flexible, polyglycolic acid tube which has been heat treated to achieve a configuration corrugated externally for wall strength. The tube is 2.3 mm in diameter and 4 cm in length.
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