FDA 510(k) Application Details - K083852

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K083852
Device Name System, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DRIVE
KNOXVILLE, TN 37932 US
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Contact ALAINE MEDIO
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 12/24/2008
Decision Date 03/23/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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