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510(k) Data Aggregation

    K Number
    K093067
    Device Name
    LIPOSE DISPOSABLE CANNULA
    Manufacturer
    LIPOSE CORP.
    Date Cleared
    2009-12-29

    (90 days)

    Product Code
    QPB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIPOSE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lipose Disposable Cannula is intended for use in aesthetic body contouring.
    Device Description
    The Lipose Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock connector or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites pre-lipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Lipose Disposable Cannulas are single-use disposables, supplied sterile (gamma radiation), packaged in a PETG tray sealed with a labeled or pre-printed Tyvek lid.
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    K Number
    K081848
    Device Name
    LIPOSE FAT TRANSFER SYSTEM
    Manufacturer
    LIPOSE CORP.
    Date Cleared
    2008-12-04

    (157 days)

    Product Code
    MUU, CLA
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIPOSE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lipose Fat Transfer System is intended to be used in the aspiration, harvesting, filtering and reinjecting of autologous fat.
    Device Description
    The Lipose Fat Transfer System is a single-use disposable kit used in aspiration, harvesting, filtering, and transferring of autologus fat. The Lipose Fat Transfer System simplifies the collection and transfer autologous fat used in body contouring. The materials that comprise the Lipose Fat Transfer System are used routinely in similar devices and the predicate devices.
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