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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, Female, Mini-Sling
510(k) Number K070065
Device Name AMS SINGLE INCISION SLING SYSTEM (SIS-0)
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
PAH  
Date Received01/08/2007
Decision Date 03/01/2007
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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