FDA 510(k) Application Details - K073138

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

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510(K) Number K073138
Device Name System, X-Ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact STEPHEN SLAVENS
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 11/07/2007
Decision Date 02/26/2008
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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