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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K041511
Device Name TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
Applicant
SUTURES INDIA PRIVATE LIMITED
118, 3RD PHASE
PEENYA INDUSTRIAL AREA
BANGALORE,  IN 560-058
Applicant Contact L.G. CHANDRASEKHAR
Correspondent
SUTURES INDIA PRIVATE LIMITED
118, 3RD PHASE
PEENYA INDUSTRIAL AREA
BANGALORE,  IN 560-058
Correspondent Contact L.G. CHANDRASEKHAR
Regulation Number878.5010
Classification Product Code
GAW  
Date Received06/07/2004
Decision Date 06/03/2005
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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