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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 K211544
Device Name Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Applicant Contact Chiara Cunico
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Correspondent Contact Chiara Cunico
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/19/2021
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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