FDA 510(k) Application Details - K971717

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

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510(K) Number K971717
Device Name System, X-Ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN, NJ 08830 US
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Contact JING ZHANG
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 05/09/1997
Decision Date 09/03/1997
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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