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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 K102815
Device Name SURELIFT PROLAPSE SYSTEM
Original Applicant
NEOMEDIC INTERNATIONAL
7307 glouchester drive
edina,  MN  55435
Original Contact jeffrey r shideman
Regulation Number878.3300
Classification Product Code
OTP  
Date Received10/12/2010
Decision Date 07/07/2011
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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