FDA 510(k) Application Details - K974096

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K974096
Device Name	Shunt, Central Nervous System And Components
Applicant	PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. NORRISTOWN, PA 19403 US Other 510(k) Applications for this Company
Contact	DAVID KUNIN 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	10/30/1997
Decision Date	12/08/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review