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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 K121498
Model TXU2
Device Name PERCUNAV
Applicant
PHILIPS HEALTHCARE
49 spadina avenue
#310
toronto, 
Contact tara mackinnon
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/21/2012
Decision Date 12/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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