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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
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
595 MINER RD.
HIGHLAND HGTS.,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/16/2003
Decision Date 10/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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