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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
Device Name PERCUNAV
Original Applicant
PHILIPS HEALTHCARE
49 spadina avenue
#310
toronto,  CA m5v 2j1
Original Contact tara mackinnon
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/21/2012
Decision Date 12/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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