FDA 510(k) Application Details - K161704

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K161704
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	BIOTEX, INC. 114 HOLMES RD HOUSTON, TX 77045 US Other 510(k) Applications for this Company
Contact	RICHARD WAITE 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	06/20/2016
Decision Date	12/01/2016
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