FDA 510(k) Application Details - K130755

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K130755
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	ADEOR MEDICAL AG KIRCHPLATZ 1 PULLACH 82049 DE Other 510(k) Applications for this Company
Contact	FABIO VON ZEPPELIN 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	03/19/2013
Decision Date	06/27/2014
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