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

    LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100

    K Number: K083455 · Decision May 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    178

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    Basic Information

    Device Name
    LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
    K Number
    K083455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Khan USA, Inc.
    Date Received
    November 21, 2008
    Decision Date
    May 18, 2009
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

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    Other Clearances by Medi-Khan USA, Inc.

    K Number Device Name
    K121703 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE