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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, For Stress Urinary Incontinence, Male
510(k) Number K053371
Device Name AMS MALE TRANSOBTURATOR SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact FRANK B FREEDMAN
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact FRANK B FREEDMAN
Regulation Number878.3300
Classification Product Code
OTM  
Date Received12/05/2005
Decision Date 02/03/2006
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
Recalls CDRH Recalls
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