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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 K982403
Device Name BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Applicant
Brennen Medical, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Applicant Contact KENNETH B HERLAND
Correspondent
Brennen Medical, Inc.
1290 Hammond Rd.
St, Paul,  MN  55110
Correspondent Contact KENNETH B HERLAND
Regulation Number878.3300
Classification Product Code
PAG  
Date Received07/10/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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