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510(k) Data Aggregation

    K Number
    K071776
    Device Name
    ANEUROPLASTIC, MODEL 43-1290
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2007-07-26

    (27 days)

    Product Code
    JXH
    Regulation Number
    882.5030
    Why did this record match?
    Product Code :

    JXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.
    Device Description
    Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made: A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.
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