FDA 510(k) Application Details - K093234

Device Classification Name System, Image Processing, Radiological

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510(K) Number K093234
Device Name System, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE BP 34
BUC CEDEX 78533 FR
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Contact SOPHIE LE LOARER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/15/2009
Decision Date 10/30/2009
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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