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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name motor, drill, electric
510(k) Number K213697
Device Name ORiGO System
Bien-Air Surgery SA
Rue de l'Ouest 2b
Le Noirmont,  CH 2340
Applicant Contact Jonas Guerdat
Ken Block Consulting LLC
800 East Campbell Road, Suite 202
Richardson,  TX  75081
Correspondent Contact Akiko Dohi
Regulation Number882.4360
Classification Product Code
Subsequent Product Code
Date Received11/23/2021
Decision Date 10/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No