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510(k) Data Aggregation

    K Number
    K033395
    Device Name
    CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2004-02-25

    (125 days)

    Product Code
    GXO, GXQ
    Regulation Number
    882.5900
    Why did this record match?
    Product Code :

    GXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CODMAN Dural Graft Implant is intended for use in procedures where the repair or substitute of the patient's dura mater is needed.
    Device Description
    The CODMAN Dural Graft Implant is a collagen sponge manufactured from processed bovine tendons. It is a sterile, absorbable implant intended for the repair of the patient's dura matter. The CODMAN Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.
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    K Number
    K961802
    Device Name
    PRECLUDE SYNBLOC MEMBRANE
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    1996-07-31

    (83 days)

    Product Code
    GXO
    Regulation Number
    882.5900
    Why did this record match?
    Product Code :

    GXO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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