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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K142505
FOIA Releasable 510(k) K142505
Device Name ClearPoint System
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 Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
ORR  
Date Received09/05/2014
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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