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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.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact PETER CECCHINI
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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