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510(k) Data Aggregation
K Number
K092224Device Name
TIGR SURGICAL MESH , MODEL WK-6
Manufacturer
NOVUS SCIENTIFIC PTE LTD
Date Cleared
2010-01-25
(186 days)
Product Code
FTL, REG
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
NOVUS SCIENTIFIC PTE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
Device Description
TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The first fiber, making up 40% of the matrix by weight, is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate. The second fiber, making up 60% of the matrix by weight, is a copolymer of polylactide, and polytrimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
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