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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 K033568
FOIA Releasable 510(k) K033568
Device Name GYNECARE TVT OBTURATOR SYSTEM
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact SEAN O'BRYAN
Correspondent
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact SEAN O'BRYAN
Regulation Number878.3300
Classification Product Code
OTN  
Date Received11/12/2003
Decision Date 12/08/2003
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
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