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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 K200079
Device Name ClearPoint System and Accessories
Applicant
Mri Interventions, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Pete Piferi
Correspondent
Hogan Lovells US LLP
555 Thirteen St., NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/14/2020
Decision Date 02/13/2020
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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