FDA 510(k) Application Details - K962761

Device Classification Name	Instrument, Shunt System Implantation   More FDA Info for this Device
510(K) Number	K962761
Device Name	Instrument, Shunt System Implantation
Applicant	COOK, INC. 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	882.4545   More FDA Info for this Regulation Number
Classification Product Code	GYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/1996
Decision Date	10/11/1996
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