FDA 510(k) Application Details - K161605

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K161605
Device Name	Shunt, Central Nervous System And Components
Applicant	AQUEDUCT CRITICAL CARE, INC. 11822 NORTH CREEK PARKWAY NORTH SUITE 110 Bothell, WA 98011 US Other 510(k) Applications for this Company
Contact	Thomas Clement Other 510(k) Applications for this Contact
Regulation Number	882.5550   More FDA Info for this Regulation Number
Classification Product Code	JXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2016
Decision Date	10/27/2016
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