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FDA 510(k) Application Details - K071068
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K071068
Device Name
System, Tomography, Computed, Emission
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DRIVE
KNOXVILLE, TN 37932 US
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Contact
CRISTIN WETHERBEE
Other 510(k) Applications for this Contact
Regulation Number
892.1200
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Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
04/16/2007
Decision Date
05/14/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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