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

    KENSEY NASH ECM SURGICAL PATCH

    K Number: K094061 · Decision May 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    6
    Review Days
    138

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    Basic Information

    Device Name
    KENSEY NASH ECM SURGICAL PATCH
    K Number
    K094061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kensey Nash Corporation
    Date Received
    December 31, 2009
    Decision Date
    May 18, 2010
    Product Code
    FTM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTM Mesh, Surgical

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    K060917 KENSEY NASH BONE VOID FILLER
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