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510(k) Data Aggregation
K Number
K993362Device Name
HYLASINE
Manufacturer
BIOMATRIX, INC.
Date Cleared
2000-03-13
(159 days)
Product Code
EMX, 77E
Regulation Number
874.4100Why 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
K994170Device Name
HYLASHIELD CL
Manufacturer
BIOMATRIX, INC.
Date Cleared
2000-03-02
(83 days)
Product Code
MRC
Regulation Number
886.5918Why 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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