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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 K131229
Device Name SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55343
Applicant Contact TODD HILDEBRANDT
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55343
Correspondent Contact TODD HILDEBRANDT
Regulation Number878.3300
Classification Product Code
OTN  
Date Received04/30/2013
Decision Date 12/05/2013
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
Recalls CDRH Recalls
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