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

    QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING

    K Number: DEN070002 · Decision Feb 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    657

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    Basic Information

    Device Name
    QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
    K Number
    DEN070002
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4015
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Quick-Med Technologies, Inc.
    Date Received
    May 10, 2007
    Decision Date
    February 25, 2009
    Product Code
    NYS
    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
    NYS Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

    Other Clearances by Quick-Med Technologies, Inc.

    K Number Device Name
    K121898 STAY FRESH SKIN FOLD MANAGEMENT TEXTILE