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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 K910498
Device Name MAGNETOM 42 SP AND 63 SP
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact STEPHEN K DEOL
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact STEPHEN K DEOL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/05/1991
Decision Date 03/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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