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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fixation, non-absorbable or absorbable, for pelvic use
510(k) Number K120831
Device Name ANCHORSURE
Original Applicant
NEOMEDIC INTERNATIONAL S.L.
7307 glouchester drive
edina,  MN  55435
Original Contact jeffrey r shideman
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received03/19/2012
Decision Date 10/12/2012
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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