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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, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K071512
Device Name GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
Original Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville,  NJ  08876 -0151
Original Contact bryan a lisa
Regulation Number878.3300
Classification Product Code
OTP  
Date Received06/04/2007
Decision Date 05/15/2008
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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