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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K191479
Device Name Velocity Alpha Highspeed Surgical Drill System
Applicant
adeor Medical AG
Biberger Str. 93
Unterhaching,  DE 82008
Applicant Contact Viktor Rundel
Correspondent
adeor Medical AG
Biberger Str. 93
Unterhaching,  DE 82008
Correspondent Contact Ulrike Winkler
Regulation Number882.4310
Classification Product Code
HBE  
Date Received06/04/2019
Decision Date 04/11/2021
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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