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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 K222519
Device Name ClearPoint System
Applicant
ClearPoint Neuro, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Mary McNamara-Cullinane
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
ORR  
Date Received08/19/2022
Decision Date 09/16/2022
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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