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    K Number
    K160101
    Device Name
    SinuBand
    Manufacturer
    BIOINSPIRE TECHNOLOGIES, INCORPORATED
    Date Cleared
    2016-07-27

    (190 days)

    Product Code
    QJL, LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOINSPIRE TECHNOLOGIES, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.
    Device Description
    SinuBand is a sterile, single-use, bioresorbable two-layer film designed to be a temporary nasal dressing applied under endoscopic visualization after sinus surgery. SinuBand is composed of two layers, with one side designed to be placed against the nasal tissue and the other facing the nasal cavity.
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