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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 K033357
Device Name ACQSIM-MULTISLICE-CT, MODEL 453567042271
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner road
highland hts.,  OH  44143
Original Contact robert b smith
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/22/2003
Decision Date 01/09/2004
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
Recalls CDRH Recalls
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