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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K122768
Device Name GENESIS
Original Applicant
DORNIER MEDTECH AMERICA, INC.
555 thirteenth street, nw
washington,  DC  20004
Original Contact john j smith
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/10/2012
Decision Date 01/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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