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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 pelvic organ prolapse, transvaginally placed
510(k) Number K121612
Device Name ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
Original Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka,  MN  55343
Original Contact ngoc linh pham latchman
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received06/01/2012
Decision Date 07/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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