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

    RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS

    K Number: K082211 · Decision Nov 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    9
    Review Days
    100

    Basic Information

    Device Name
    RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
    K Number
    K082211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew, Inc
    Date Received
    August 6, 2008
    Decision Date
    November 14, 2008
    Product Code
    OMP
    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
    OMP Negative Pressure Wound Therapy Powered Suction Pump

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