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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, Silk
510(k) Number K041514
Device Name TRUESILK NON-ABSORBABLE SILK 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 Number878.5030
Classification Product Code
GAP  
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
Predetermined Change
Control Plan Authorized		 No
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