FDA 510(k) Application Details - K162542

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K162542
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	OSTEOMED 3885 ARAPAHO ROAD ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	KATHRYN A. JAYNE 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	09/12/2016
Decision Date	05/19/2017
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