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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,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
MAZOR ROBOTICS LTD
20 HATA'AS ST. BOX 124
SUITE 213 BEIT HAPA'AMON
KFAR SABA,  IL 44425
Correspondent 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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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