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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 K070224
Device Name ULTRAPRO PLUG
Applicant
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact BRYAN A LISA
Correspondent
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact BRYAN A LISA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/24/2007
Decision Date 04/17/2007
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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