FDA 510(k) Application Details - K183515

Device Classification Name	Motor, Drill, Electric   More FDA Info for this Device
510(K) Number	K183515
Device Name	Motor, Drill, Electric
Applicant	Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 US Other 510(k) Applications for this Company
Contact	Jenna Groves Other 510(k) Applications for this Contact
Regulation Number	882.4360   More FDA Info for this Regulation Number
Classification Product Code	HBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2018
Decision Date	05/12/2019
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