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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K060018
Device Name TRULENE MESH
Applicant
SUTURES INDIA PVT., LTD.
472 D, 13TH CROSS, 4TH PHASE
PEENYA INDUSTRIAL AREA
BANGALORE,  IN 560058
Applicant Contact L.G. CHANDRASEKHAR
Correspondent
SUTURES INDIA PVT., LTD.
472 D, 13TH CROSS, 4TH PHASE
PEENYA INDUSTRIAL AREA
BANGALORE,  IN 560058
Correspondent Contact L.G. CHANDRASEKHAR
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/04/2006
Decision Date 07/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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