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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, angiographic
510(k) Number K031333
Device Name PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL 5680
Applicant Contact LYNN HARMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact LYNN HARMER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received04/28/2003
Decision Date 05/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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