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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 K121641
Device Name MINIARC PRO SINGLE-INCISION SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55343
Applicant Contact RENEE MELLUM
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55343
Correspondent Contact RENEE MELLUM
Regulation Number878.3300
Classification Product Code
PAH  
Date Received06/04/2012
Decision Date 09/07/2012
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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