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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K223734
Device Name ENT EM
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
PGW  
Subsequent Product Code
HAW  
Date Received12/13/2022
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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