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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurological stereotaxic instrument
510(K) Number K120812
Device Name RENAISSANCE
Applicant
MAZOR ROBOTICS LTD
20 hata'as st. box 124
suite 213 beit hapa'amon
kfar saba, 
Contact ahava stein
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
LLZ  
Date Received03/16/2012
Decision Date 07/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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