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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 K102130
FOIA Releasable 510(k) K102130
Device Name TENZING SYSTEM
Applicant
Mazor Surgical Technologies , Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Mazor Surgical Technologies , Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
LLZ  
Date Received07/29/2010
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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