FDA 510(k) Application Details - K113476

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K113476
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Bch Gdns, FL 33410 US Other 510(k) Applications for this Company
Contact	JEANNETTE G DAILEY 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	11/22/2011
Decision Date	12/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review