FDA 510(k) Application Details - K150378

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K150378
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	NICO Corporation 250 E 96TH ST Suite 125 Indianapolis, IN 46240 US Other 510(k) Applications for this Company
Contact	Sean Spence Other 510(k) Applications for this Contact
Regulation Number	882.4800   More FDA Info for this Regulation Number
Classification Product Code	GZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2015
Decision Date	06/12/2015
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