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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K081672
FOIA Releasable 510(k) K081672
Device Name C-INSIGHT
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 Number892.2050
Classification Product Code
LLZ  
Date Received06/13/2008
Decision Date 08/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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