FDA 510(k) Application Details - K082010

Device Classification Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)   More FDA Info for this Device
510(K) Number	K082010
Device Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant	STRYKER IRELAND LTD., INSTRUMENTS DIVISION CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK CARRIGTWOHILL, CO.CORK IE Other 510(k) Applications for this Company
Contact	COLETTE O'CONNOR 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	07/15/2008
Decision Date	12/29/2008
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