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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
Applicant
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL,  WA  98041 -8431
Applicant Contact LYNN HARMER
Correspondent
PHILIPS MEDICAL SYSTEMS
22100 BOTHELL EVERETT HWY
P.O. BOX 3003
BOTHELL,  WA  98041 -8431
Correspondent Contact LYNN HARMER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/12/2003
Decision Date 09/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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