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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, Fluoroscopic, Image-Intensified
510(k) Number K020055
Device Name PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
Applicant
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
BOTHELL,  WA  98021 -8431
Applicant Contact LYNN HARMER
Correspondent
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
BOTHELL,  WA  98021 -8431
Correspondent Contact LYNN HARMER
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received01/08/2002
Decision Date 03/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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