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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 K984545
Device Name RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
Applicant
Philips Medical Systems North America, Inc.
Veenpluis 4-6
P.O. Box 10000
Da Best,  NL 5680
Applicant Contact P. ALTMAN
Correspondent
Philips Medical Systems North America, Inc.
Veenpluis 4-6
P.O. Box 10000
Da Best,  NL 5680
Correspondent Contact P. ALTMAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/22/1998
Decision Date 02/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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