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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
Applicant
American Medical Systems
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact NGOC LINH PHAM LATCHMAN
Correspondent
American Medical Systems
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact NGOC LINH PHAM LATCHMAN
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received06/01/2012
Decision Date 07/20/2012
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
Predetermined Change
Control Plan Authorized		 No
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