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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 K050845
Device Name MONOCRYL PLUS ANTIBACTERIAL SUTURE
Applicant
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact JENNIFER M PAINE
Correspondent
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact JENNIFER M PAINE
Regulation Number878.4493
Classification Product Code
GAM  
Date Received04/04/2005
Decision Date 06/29/2005
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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