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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K080624
Device Name NAVSTATIONIRAD EMT, VERSION 1.1
Original Applicant
CAS INNOVATIONS AG
heuteg 47
erlangen,  GM 91056
Original Contact markus nagel
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/05/2008
Decision Date 04/11/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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