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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 K090038
Device Name SYNGO BREVIS
Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Applicant Contact JUDITH CAMPBELL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Correspondent Contact JUDITH CAMPBELL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/06/2009
Decision Date 04/28/2009
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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