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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 K063713
Device Name AMS SMART SLING SYSTEM
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Applicant Contact BRAD ONSTAD
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Correspondent Contact BRAD ONSTAD
Regulation Number878.3300
Classification Product Code
OTN  
Date Received12/14/2006
Decision Date 02/22/2007
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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