FDA 510(k) Application Details - K013488

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K013488
Device Name	Shunt, Central Nervous System And Components
Applicant	SOPHYSA SA 70 WALNUT ST. WELLESLEY, MA 02481 US Other 510(k) Applications for this Company
Contact	JACQUELINE E MASSE 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	10/19/2001
Decision Date	03/27/2002
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