FDA 510(k) Application Details - K053024

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

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510(K) Number K053024
Device Name System, X-Ray, Tomography, Computed
Applicant SIEMENS AG
SIEMENSSTR. 1
FORCHHEIM D-91301 DE
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Contact RUEDIGER KOERNER
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 10/21/2005
Decision Date 11/04/2005
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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