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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 K230619
Device Name Hubly Electric Drill (H100)
Applicant
Hubly Inc.
750 Warrenville Rd
Suite 303
Lisle,  IL  60532
Applicant Contact Casey Grage
Correspondent
Hubly Inc.
750 Warrenville Rd
Suite 303
Lisle,  IL  60532
Correspondent Contact Julie Byars
Regulation Number882.4310
Classification Product Code
HBE  
Date Received03/06/2023
Decision Date 05/04/2023
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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