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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 K071249
FOIA Releasable 510(k) K071249
Device Name ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Applicant
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact PATRICE NAPODA
Correspondent
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact PATRICE NAPODA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/04/2007
Decision Date 06/05/2007
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
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