FDA 510(k) Application Details - K153587

Device Classification Name	Drills, Burrs, Trephines & Accessories (Manual)   More FDA Info for this Device
510(K) Number	K153587
Device Name	Drills, Burrs, Trephines & Accessories (Manual)
Applicant	SYNTHES (USA) PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Susan Lewandowski Other 510(k) Applications for this Contact
Regulation Number	882.4300   More FDA Info for this Regulation Number
Classification Product Code	HBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2015
Decision Date	01/18/2017
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