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510(k) Data Aggregation

    K Number
    K993362
    Device Name
    HYLASINE
    Manufacturer
    BIOMATRIX, INC.
    Date Cleared
    2000-03-13

    (159 days)

    Product Code
    EMX, 77E
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.
    Device Description
    Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
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    K Number
    K994170
    Device Name
    HYLASHIELD CL
    Manufacturer
    BIOMATRIX, INC.
    Date Cleared
    2000-03-02

    (83 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hylashield® CL Lubricating Eye Drops are indicated for lubricating and wetting/rewetting rigid gas permeable contact lenses.
    Device Description
    Hylashield® CL Lubricating Eye Drop is a sterile, isotonic, preservative-free, clear, elastoviscous, ophthalmic solution presented in a single-use container. It contains hylan fluid, a viscous, elastic and biocompatible substance derived from the natural polysaccharide, hyaluronan. It lubricates and wets/rewets your lenses, thereby providing prolonged relief from symptoms of ocular discomfort associated with the use of rigid gas permeable contact lenses.
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