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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 K151536
Device Name SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
Applicant
Mri Interventions, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact E F WADDELL
Correspondent
Mri Interventions, Inc.
5 Musick
Irvine,  CA  92618
Correspondent Contact E F WADDELL
Regulation Number882.4300
Classification Product Code
HBG  
Date Received06/08/2015
Decision Date 07/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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