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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 K051485
Device Name AMS PELVIC FLOOR REPAIR SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Original Contact elsa linke
Regulation Number878.3300
Classification Product Code
OTO  
Subsequent Product Code
OTP  
Date Received06/06/2005
Decision Date 08/03/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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