FDA 510(k) Application Details - K033832

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K033832
Device Name System, X-Ray, Tomography, Computed
Applicant SIEMENS AG, MEDICAL SOLUTIONS
SIEMENSSTRASSE 1
FORCHHEIM D 91301 DE
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Contact RUDIGER KORNER
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 12/10/2003
Decision Date 12/23/2003
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 Y
Expedited Review



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