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

    LTM WOUND DRESSING

    K Number: K082103 · Decision Oct 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    75

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    Basic Information

    Device Name
    LTM WOUND DRESSING
    K Number
    K082103
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifecell Corp.
    Date Received
    July 25, 2008
    Decision Date
    October 8, 2008
    Product Code
    KGN
    Advisory Committee
    Unknown
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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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
    K080353 LTM-T SURGICAL MESH
    K071986 LTM-RC SURGICAL MESH
    K070560 LRTM SURGICAL MESH
    K061208 LIFECELL DURAL SUBSTITUTE MATRIX
    K052735 ALLOCRAFT DBM