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

    LIFECELL DURAL SUBSTITUTE MATRIX

    K Number: K061208 · Decision Jan 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    10
    Review Days
    247

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    Basic Information

    Device Name
    LIFECELL DURAL SUBSTITUTE MATRIX
    K Number
    K061208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifecell Corp.
    Date Received
    May 1, 2006
    Decision Date
    January 3, 2007
    Product Code
    GXQ
    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
    GXQ Dura Substitute

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    Other Clearances by Lifecell Corp.

    K Number Device Name
    K130817 LTN - LAPAROSCOPIC SURGICAL MESH
    K112534 LIFECELL TISSUE EXPANDER
    K121289 LTM-LABAROSCOPIC SURGICAL MESH
    K082176 LTM-BPS SURGICAL MESH
    K082103 LTM WOUND DRESSING
    K080353 LTM-T SURGICAL MESH
    K071986 LTM-RC SURGICAL MESH
    K070560 LRTM SURGICAL MESH
    K052735 ALLOCRAFT DBM