FDA 510(k) Application Details - K033704

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K033704
Device Name	Shunt, Central Nervous System And Components
Applicant	VYGON US LLC 2495 GENERAL ARMSTEAD AVE. NORRISTOWN, PA 19403 US Other 510(k) Applications for this Company
Contact	COURTNEY SMITH 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	11/25/2003
Decision Date	05/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review