FDA 510(k) Application Details - K231664

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K231664
Device Name	Shunt, Central Nervous System And Components
Applicant	IRRAS USA Inc. 11975 El Camino Real, Suite 304 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Jeanne S. Warner 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	06/07/2023
Decision Date	10/19/2023
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