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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 K923813
Device Name PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL
Applicant Contact WILLIAM G MCMAHON
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/29/1992
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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