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

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

    K Number: K142956 · Decision Feb 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
    K Number
    K142956
    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
    October 14, 2014
    Decision Date
    February 24, 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

    K Number Device Name
    K143301 NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit