LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K090162
    Device Name
    EVICEL APPLICATION DEVICE
    Manufacturer
    OMRIX BIOPHARMACEUTICALS LTD.
    Date Cleared
    2009-02-20

    (29 days)

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

    OMRIX BIOPHARMACEUTICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVICELTM 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 (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.
    Device Description
    Not Found
    Ask a Question
    K Number
    K070575
    Device Name
    EVICEL APPLICATION DEVICE
    Manufacturer
    OMRIX BIOPHARMACEUTICALS LTD.
    Date Cleared
    2007-05-29

    (90 days)

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

    OMRIX BIOPHARMACEUTICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVICEL TM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL TM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO 2 pressure utilizing the pressure regulator unit) onto the surface.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1