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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, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
510(k) Number K031295
Device Name BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact FRANCES E HARRISON
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact FRANCES E HARRISON
Regulation Number878.3300
Classification Product Code
PAG  
Date Received04/23/2003
Decision Date 05/15/2003
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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