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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
Applicant
NEOMEDIC INTERNATIONAL
7307 GLOUCHESTER DRIVE
EDINA,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
NEOMEDIC INTERNATIONAL
7307 GLOUCHESTER DRIVE
EDINA,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number884.5980
Classification Product Code
OTP  
Date Received09/28/2010
Decision Date 07/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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