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

    NOVOPORE DRESSING

    K Number: K132936 · Decision Mar 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    6
    Review Days
    167

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    Basic Information

    Device Name
    NOVOPORE DRESSING
    K Number
    K132936
    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
    Polynovo Biomaterials Pty, Ltd.
    Date Received
    September 18, 2013
    Decision Date
    March 4, 2014
    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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    Other Clearances by Polynovo Biomaterials Pty, Ltd.

    K Number Device Name
    K251567 NovoSorb BTM
    K242149 NovoSorb® MTX
    K221686 NovoSorb Matrix
    K172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
    K142879 BTM Wound Dressing