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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
510(k) Number K181151
Device Name GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
Applicant
Ethicon, Inc.
Route 22 W.
Somerville,  NJ  08876
Applicant Contact Debbie Fazen
Correspondent
Ethicon, Inc.
Route 22 W.
Somerville,  NJ  08876
Correspondent Contact Debbie Fazen
Regulation Number884.4910
Classification Product Code
PWJ  
Date Received05/01/2018
Decision Date 08/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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