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

    NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

    K Number: K143301 · Decision Mar 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    2
    Review Days
    106

    Basic Information

    Device Name
    NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
    K Number
    K143301
    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
    Integrated Healing Technologies
    Date Received
    November 17, 2014
    Decision Date
    March 3, 2015
    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 Integrated Healing Technologies

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    K142956 NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit