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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 stress urinary incontinence, retropubic or transobturator
510(k) Number K012628
Device Name GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
Original Applicant
GYNECARE CENTER
p.o. box 151
somerville,  NJ  08876 0151
Original Contact gregory jones
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/13/2001
Decision Date 10/26/2001
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
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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