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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 K063562
Device Name GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
Original Applicant
ETHICON, INC.
p.o. box 151
route 22 west
somerville,  NJ  08876
Original Contact patrice nagoda
Regulation Number878.3300
Classification Product Code
OTP  
Date Received11/27/2006
Decision Date 02/26/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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