FDA 510(k) Application Details - K231403

Device Classification Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)   More FDA Info for this Device
510(K) Number	K231403
Device Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant	Evonos GmbH & Co. KG Stockacher Strasse 134 Tuttingen 78532 DE Other 510(k) Applications for this Company
Contact	J÷rg Mans Other 510(k) Applications for this Contact
Regulation Number	882.4305   More FDA Info for this Regulation Number
Classification Product Code	HBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2023
Decision Date	03/06/2024
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