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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K234047
Device Name Automatic Registration
Applicant
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Applicant Contact Esther Moreno Garcia
Correspondent
Brainlab AG
Olof-Palme-Str.9
Munich,  DE 81829
Correspondent Contact Esther Moreno Garcia
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/21/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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