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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 K002016
Device Name PHILIPS INTEGRIS ALLURA
Applicant
Philips Medical Systems North America, Inc.
Veenpluis 4-6
P.O. Box 10000
Da Best,  NL 5680
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems North America, Inc.
Veenpluis 4-6
P.O. Box 10000
Da Best,  NL 5680
Correspondent Contact PETER ALTMAN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/03/2000
Decision Date 09/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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