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

    Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set

    K Number: K161418 · Decision Jan 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    32
    Review Days
    241

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    Basic Information

    Device Name
    Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
    K Number
    K161418
    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
    Cardinalhealth
    Date Received
    May 23, 2016
    Decision Date
    January 19, 2017
    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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