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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 K993731
Device Name SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Applicant Contact kathleen rutherford
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Correspodent Contact kathleen rutherford
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/04/1999
Decision Date 12/23/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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