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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 K022269
Device Name COATED VICRYL* (POLYGLACTIN 910) SUTURE
Applicant
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Applicant Contact LEA ANN CONWAY
Correspondent
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Correspondent Contact LEA ANN CONWAY
Regulation Number878.4493
Classification Product Code
GAM  
Date Received07/15/2002
Decision Date 09/13/2002
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
Recalls CDRH Recalls
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