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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 K082216
Device Name TBD ETHICON MESH
Original Applicant
ETHICON INC.
route 22 west
po box 151
somerville,  NJ  08876
Original Contact bryan a lisa
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/06/2008
Decision Date 09/05/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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