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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 K132054
Device Name GYNECARE TVT EXACT CONTINENCE SYSTEM
Applicant
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Applicant Contact SUSAN LIN
Correspondent
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact SUSAN LIN
Regulation Number878.3300
Classification Product Code
OTN  
Date Received07/03/2013
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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