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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K133198
Device Name ULTRAPRO COMFORT PLUG
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact REYNALDO LIBROJO
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact REYNALDO LIBROJO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/17/2013
Decision Date 05/30/2014
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
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