FDA 510(k) Application Details - K200807

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K200807
Device Name	Shunt, Central Nervous System And Components
Applicant	IRRAS USA Inc. 11975 El Camino Real San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Niloufa Insanally 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	03/27/2020
Decision Date	04/29/2020
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