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

    MICROAIRE SURGICAL INSTRUMENTS LLC

    K Number: K113128 · Decision Aug 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    9
    Review Days
    298

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    Basic Information

    Device Name
    MICROAIRE SURGICAL INSTRUMENTS LLC
    K Number
    K113128
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microaire Surgical Instruments, LLC
    Date Received
    October 24, 2011
    Decision Date
    August 17, 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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    Other Clearances by Microaire Surgical Instruments, LLC

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    K181819 SMARTRELEASE Endoscopic Soft Tissue Release System
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