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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 K933791
Device Name PHILIPS ANGIOPRO RELEASE 2.1
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Applicant Contact WILLIAM G MCMAHON
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/04/1993
Decision Date 11/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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