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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 K031815
Device Name INTERA-SENSATION FAMILY
Original Applicant
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
p.o. box 3003
bothell,  WA  98041 8431
Original Contact lynn harmer
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/12/2003
Decision Date 09/10/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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