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510(k) Data Aggregation

    K Number
    K080158
    Device Name
    LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
    Manufacturer
    LB MEDICAL L.L.C.
    Date Cleared
    2008-05-02

    (100 days)

    Product Code
    FZW, LCJ
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    LB MEDICAL L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.
    Device Description
    The subject device is similar to a traditional elevator, but features a manually inflatable balloon component at the distal end. The balloon is inflated/deflated with saline via a manual inflation syringe system with an integral pressure gauge.
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