FDA 510(k) Application Details - K972360

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K972360
Device Name System, Tomography, Computed, Emission
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES, IL 60195-7372 US
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Contact PAUL G ORIS
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 06/25/1997
Decision Date 09/23/1997
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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