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

    XLR8 Abdominal Wound Dressing Kit

    K Number: K182722 · Decision Sep 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    2
    Review Days
    364

    Basic Information

    Device Name
    XLR8 Abdominal Wound Dressing Kit
    K Number
    K182722
    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
    Genadyne Biotechnologies
    Date Received
    September 28, 2018
    Decision Date
    September 27, 2019
    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 Genadyne Biotechnologies

    K Number Device Name
    K190028 UNO 30