FDA 510(k) Application Details - K081942

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K081942
Device Name	Shunt, Central Nervous System And Components
Applicant	VYGON NEURO 2495 GENERAL ARMISTEAD 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	07/08/2008
Decision Date	08/12/2008
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