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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K072567
Device Name SYMBIA-E, MODEL 10275879
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60192
Applicant Contact ALAINE MEDIO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60192
Correspondent Contact ALAINE MEDIO
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/12/2007
Decision Date 10/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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