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

    LipoFilter - Hospital Pack, LipoFilter - Clinic Pack

    K Number: K150779 · Decision May 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
    K Number
    K150779
    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
    Microaire Surgical Instruments, LLC
    Date Received
    March 25, 2015
    Decision Date
    May 22, 2015
    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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