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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 K132580
Device Name COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
Applicant
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact PETER CECCHINI
Correspondent
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Correspondent Contact PETER CECCHINI
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/16/2013
Decision Date 02/28/2014
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
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