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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, Pneumatic
510(k) Number K253772
Device Name Velocity Alpha MR High Speed Surgical Drill System
Applicant
Adeor Medical AG
Martinshof 5
Valley,  DE 83626
Applicant Contact Silvia Laube
Correspondent
Adeor Medical AG
Martinshof 5
Valley,  DE 83626
Correspondent Contact Silvia Laube
Regulation Number882.4370
Classification Product Code
HBB  
Subsequent Product Code
HBE  
Date Received11/26/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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