FDA 510(k) Application Details - K072952

Device Classification Name System, Image Processing, Radiological

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510(K) Number K072952
Device Name System, Image Processing, Radiological
Applicant GENERAL ELECTRIC CO.
9900 Innovation Drive
Wauwatosa, WI 53226 US
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Contact ALLEN SCHUH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/18/2007
Decision Date 11/16/2007
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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