FDA 510(k) Application Details - K112598

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K112598
Device Name	Neurosurgical Paddie
Applicant	AMERICAN SURGICAL COMPANY, LLC 82 SANDERSON AVENUE LYNN, MA 01902 US Other 510(k) Applications for this Company
Contact	MICHAEL ALOUANE Other 510(k) Applications for this Contact
Regulation Number	882.4700   More FDA Info for this Regulation Number
Classification Product Code	HBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2011
Decision Date	06/20/2013
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