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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K990335
Device Name PHILIPS EASYVISION WORKSTATION:
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484 -0197
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON,  CT  06484 -0197
Correspondent Contact PETER ALTMAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/03/1999
Decision Date 09/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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