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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
Applicant
Gynecare Center
P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact GREGORY JONES
Correspondent
Gynecare Center
P.O. Box 151
Somerville,  NJ  08876 -0151
Correspondent Contact GREGORY JONES
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/13/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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