FDA 510(k) Application Details - K101168

Device Classification Name	Motor, Drill, Pneumatic   More FDA Info for this Device
510(K) Number	K101168
Device Name	Motor, Drill, Pneumatic
Applicant	MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	THERESA LEISTER Other 510(k) Applications for this Contact
Regulation Number	882.4370   More FDA Info for this Regulation Number
Classification Product Code	HBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2010
Decision Date	08/24/2010
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