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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., WEST
MINNETONKA,  MN  55343
Applicant Contact BRAD ONSTAD
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
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
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