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

    SUCTION LIPOLASTY ACCESSORIES

    K Number: K113795 · Decision Aug 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    228

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    Basic Information

    Device Name
    SUCTION LIPOLASTY ACCESSORIES
    K Number
    K113795
    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
    Norman M. Black Iii
    Date Received
    December 23, 2011
    Decision Date
    August 7, 2012
    Product Code
    QPB
    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
    QPB System, Suction, Lipoplasty For Removal

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