FDA 510(k) Application Details - K230619

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K230619
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	Hubly Inc. 750 Warrenville Rd Suite 303 Lisle, IL 60532 US Other 510(k) Applications for this Company
Contact	Casey Grage Other 510(k) Applications for this Contact
Regulation Number	882.4310   More FDA Info for this Regulation Number
Classification Product Code	HBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2023
Decision Date	05/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review