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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K033782
Device Name ALLEGRO IMAGING SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact CHRISTOF LITTWITZ
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
1279 QUARRY LANE, SUITE A
PLEASANTON,  CA  94566
Correspondent Contact JUERGEN WELTE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/04/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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