FDA 510(k) Application Details - K052897

Device Classification Name System, X-Ray, Mobile

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510(K) Number K052897
Device Name System, X-Ray, Mobile
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE, WI US
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Contact MARK STAUFFER
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 10/14/2005
Decision Date 11/08/2005
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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