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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 K112842
Device Name AMS ELEVATE PC
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact MATTHEW D STEPANEK
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact MATTHEW D STEPANEK
Regulation Number884.5980
Classification Product Code
OTP  
Date Received09/29/2011
Decision Date 10/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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