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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drills, burrs, trephines & accessories (manual)
510(k) Number K122456
Device Name MRII CRAINIAL DRILL
Original Applicant
MRI INTERVENTIONS, INC.
5 musick
irvine,  CA  92618
Original Contact e.f. waddell
Regulation Number882.4300
Classification Product Code
HBG  
Date Received08/13/2012
Decision Date 03/22/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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