FDA 510(k) Application Details - K160223

Device Classification Name	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)   More FDA Info for this Device
510(K) Number	K160223
Device Name	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	STEVEN LAWRIE Other 510(k) Applications for this Contact
Regulation Number	882.4100   More FDA Info for this Regulation Number
Classification Product Code	NHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2016
Decision Date	04/08/2016
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