FDA 510(k) Application Details - K031871

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

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510(K) Number K031871
Device Name System, X-Ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS EUROPE
283, RUE DE LA MINIERE, B.P.34
BUC CEDEX 78533 FR
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Contact LARRY KROGER
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 06/17/2003
Decision Date 06/20/2003
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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