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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 apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K013718
Device Name GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
Original Applicant
GYNECARE, A DIV. OF ETHICON, INC.
p.o. box 151
somerville,  NJ  08876
Original Contact gregory r jones
Regulation Number878.3300
Classification Product Code
OTO  
Date Received11/08/2001
Decision Date 01/08/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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