FDA 510(k) Application Details - K071310

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

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510(K) Number K071310
Device Name System, X-Ray, Tomography, Computed
Applicant SIEMENS AG
SIEMENSSTRASSE 1
FORCHHEIM 91301 DE
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Contact KRISTIN FROWEIN
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 05/09/2007
Decision Date 06/08/2007
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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