FDA 510(k) Application Details - K023932

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K023932
Device Name System, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS F.I. HAIFA
4 HAYOZMA ST., P.O. BOX 170
TIRAT HACARMEL 30200 IL
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Contact HEMY NEUMAN
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 11/26/2002
Decision Date 12/11/2002
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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