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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 K032420
Device Name MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
Applicant
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Applicant Contact REY LIBROJO
Correspondent
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Correspondent Contact REY LIBROJO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/05/2003
Decision Date 10/22/2003
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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