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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 K033326
Device Name "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS, INC.
595 miner rd.
highland hgts.,  OH  44143
Original Contact robert l turocy
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/16/2003
Decision Date 10/29/2003
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
Recalls CDRH Recalls
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