FDA 510(k) Application Details - K011812

Device Classification Name	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)   More FDA Info for this Device
510(K) Number	K011812
Device Name	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Applicant	COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	APRIL LAVENDER 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	06/11/2001
Decision Date	11/08/2001
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