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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, female, mini-sling
510(k) Number K052401
Device Name GYNECARE TVT SECUR SYSTEM
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact PATRICIA M HOJNOSKI
Correspondent
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact PATRICIA M HOJNOSKI
Regulation Number878.3300
Classification Product Code
PAH  
Date Received09/01/2005
Decision Date 11/28/2005
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
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