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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 K173162
Device Name GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
Applicant
Ethicon, Inc
P.O. Box 151, Route 22 West
Somerville,  NJ  08876
Applicant Contact Julie Tom Wing
Correspondent
Ethicon, Inc
P.O. Box 151, Route 22 West
Somerville,  NJ  08876
Correspondent Contact Julie Tom Wing
Regulation Number884.4910
Classification Product Code
PWJ  
Subsequent Product Code
OTN  
Date Received09/29/2017
Decision Date 06/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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