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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 K233141
Device Name SmartFrame OR
Applicant
ClearPoint Neuro Inc.
120 S. Sierra Ave.
Suite 100
Solana Beach,  CA  92075
Applicant Contact Brennan Sullivan
Correspondent
ClearPoint Neuro Inc.
120 S. Sierra Ave.
Suite 100
Solana Beach,  CA  92075
Correspondent Contact Brennan Sullivan
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/27/2023
Decision Date 01/12/2024
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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