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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 K230195
Device Name Neo ADVISE software
Applicant
Comerge AG
Bubenbergstrasse 1
Zurich,  CH 8045
Applicant Contact Beat Hugi
Correspondent
Confinis Ag
Hauptrasse 16
Dudingen,  CH 3186
Correspondent Contact Frederike Bruhschwein-Mandic
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/25/2023
Decision Date 03/08/2024
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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