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

    TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500

    K Number: K092482 · Decision Dec 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    13
    Review Days
    113

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    Basic Information

    Device Name
    TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
    K Number
    K092482
    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
    Shippert Medical Technologies Corp.
    Date Received
    August 13, 2009
    Decision Date
    December 4, 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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