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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K113004
Device Name PDS(TM) BARBED SUTURES
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact PETER CECCHINI
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact PETER CECCHINI
Regulation Number878.4840
Classification Product Code
NEW  
Date Received10/07/2011
Decision Date 12/20/2011
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
Recalls CDRH Recalls
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