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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 K993459
Device Name MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Applicant
Advanced Uroscience, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact KAREN E PETERSON
Correspondent
Advanced Uroscience, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact KAREN E PETERSON
Regulation Number878.3300
Classification Product Code
PAG  
Date Received10/13/1999
Decision Date 11/05/1999
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
Predetermined Change
Control Plan Authorized		 No
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