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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 apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K121805
Device Name AMS LARGE PORE POLYPROPHLENE MESH
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
OTO  
Date Received06/19/2012
Decision Date 10/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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