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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 K033746
Device Name MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact REY LIBROJO
Correspondent
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact REY LIBROJO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/01/2003
Decision Date 12/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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