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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 K100936
Device Name GYNECARE TVT ABBREVO CONTINENCE SYSTEM
Applicant
ETHICON, Inc.
Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact SUSAN LIN
Correspondent
ETHICON, Inc.
Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact SUSAN LIN
Regulation Number878.3300
Classification Product Code
OTN  
Date Received04/05/2010
Decision Date 07/01/2010
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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