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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(K) Number K120721
Device Name EOS
Applicant
EOS IMAGING
555 thirteenth street, nw
washington,  DC  20004
Contact john j smith
Regulation Number892.1650
Classification Product Code
MQB  
Date Received03/08/2012
Decision Date 04/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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