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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K141979
Device Name ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
Applicant
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
VEENPLUIS 4-6
5684-PC
BEST,  NL NETHERLAND
Applicant Contact JEANETTE BECKER
Correspondent
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
VEENPLUIS 4-6
5684-PC
BEST,  NL NETHERLAND
Correspondent Contact JEANETTE BECKER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/21/2014
Decision Date 08/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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