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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
Original Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka,  MN  55343
Original Contact renee mellum
Regulation Number878.3300
Classification Product Code
OTO  
Date Received06/19/2012
Decision Date 10/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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