FDA 510(k) Application Details - K031874

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K031874
Device Name System, Tomography, Computed, Emission
Applicant U.C.G. TECHNOLOGIES LTD.
BUILDING # 30 MATAM
HAIFA 31905 IL
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Contact DAN LAOR
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 06/17/2003
Decision Date 07/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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