BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    KULAVAC

    K Number: K122490 · Decision Nov 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    5
    Review Days
    455

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    Basic Information

    Device Name
    KULAVAC
    K Number
    K122490
    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
    CG Bio Co., Ltd.
    Date Received
    August 15, 2012
    Decision Date
    November 13, 2013
    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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