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510(k) Data Aggregation

    K Number
    K041446
    Device Name
    NASALCEASE
    Manufacturer
    LES LABORATORIRES BROTHIER, S.A.
    Date Cleared
    2004-07-01

    (30 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LES LABORATORIRES BROTHIER, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.
    Device Description
    NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.
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    K Number
    K984069
    Device Name
    ENTAXIS NASAL PACKING
    Manufacturer
    LES LABORATORIRES BROTHIER, S.A.
    Date Cleared
    1999-01-25

    (70 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LES LABORATORIRES BROTHIER, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENTaxis™ Nasal Packing is intended for - Epistaxis - Post operative nasal packing
    Device Description
    ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.
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