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510(k) Data Aggregation

    K Number
    K102742
    Device Name
    NASAL CEASE
    Manufacturer
    CATALINA, INC.
    Date Cleared
    2011-02-02

    (133 days)

    Product Code
    QSYEMXFRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATALINA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device has the following intended use. NasalCEASE® is intended to be used as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and about and case is already approved for treatment of minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device. The device is not intended to be used for medium or severe wounds or bleeding.
    Device Description
    NasalCEASE® is comprised of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) of interwoven threads or as particles.
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