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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K081002
Device Name MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
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 Number878.4493
Classification Product Code
GAM  
Date Received04/08/2008
Decision Date 06/09/2008
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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