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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 K160129
Device Name MRII Cranial Drill and Accessories
Applicant
MRI INTERVENTIONS, INC.
5 MUSICK
IRVINE,  CA  92618
Applicant Contact PETER PIFERI
Correspondent
MRI INTERVENTIONS, INC.
5 MUSICK
IRVINE,  CA  92618
Correspondent Contact PETER PIFERI
Regulation Number882.4300
Classification Product Code
HBG  
Date Received01/20/2016
Decision Date 03/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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