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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 K250815
Device Name Hubly Drill (H100)
Applicant
Hubly, Inc.
815 Ogden Ave.
Lisle,  IL  60532
Applicant Contact Casey Qadir
Correspondent
Hubly, Inc.
815 Ogden Ave.
Lisle,  IL  60532
Correspondent Contact Julie Byars
Regulation Number882.4310
Classification Product Code
HBE  
Date Received03/17/2025
Decision Date 11/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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