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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K133356
Device Name PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Applicant Contact ELLIOTT JANG
Correspondent
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact ELLIOTT JANG
Regulation Number878.5010
Classification Product Code
GAW  
Date Received10/31/2013
Decision Date 12/06/2013
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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