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

    EPIFLO(R)

    K Number: K120764 · Decision Apr 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    EPIFLO(R)
    K Number
    K120764
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neogenix, LLC
    Date Received
    March 13, 2012
    Decision Date
    April 27, 2012
    Product Code
    KPJ
    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
    KPJ Chamber, Oxygen, Topical, Extremity

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