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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 K012949
Device Name URETEX SUP PUBOURETHRAL SLING
Applicant
Sofradim Production
5 Whitcomb Ave.
Ayer,  MA  01432
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Sofradim Production
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number878.3300
Classification Product Code
OTN  
Date Received09/04/2001
Decision Date 10/04/2001
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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