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510(k) Data Aggregation

    K Number
    K130900
    Device Name
    EVICEL APPLICATION DEVICE
    Manufacturer
    ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS
    Date Cleared
    2013-08-13

    (134 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant via dripping (no air pressure) or via spraying (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.
    Device Description
    The EVICEL Application device is a sterile single used to apply the two biological components of the EVICEL® Fibrin Sealant (Human). Accessory tips are also provided separately to help provide the user different options for various clinical uses. The pressure regulator (Class I, Exempt) may also be provided as an accessory to help reduce the pressure of the gas obtained from a CO2 source to within the recommended range for use.
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