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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, stationary
510(k) Number K122589
Device Name DFP4343C7
Original Applicant
MDI CONSULTANTS, INC.
55 northern boulevard
suite 200
great neck,  NY  11021
Original Contact jigar shah
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received08/24/2012
Decision Date 10/05/2012
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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