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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 K142822
Device Name PLIASURE Polyglycolide Synthetic Absorbable Suture
Applicant
ETHICON, Inc.
Rt. 22 West, P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Susan Lin
Correspondent
ETHICON, Inc.
Rt. 22 West, P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Susan Lin
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/30/2014
Decision Date 03/26/2015
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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