FDA 510(k) Application Details - K223603

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K223603
Device Name	Shunt, Central Nervous System And Components
Applicant	Anuncia Medical, Inc. 1355 N Scottsdale Rd, Suite 370 Scottsdale, AZ 85257 US Other 510(k) Applications for this Company
Contact	Elsa Chi Abruzzo 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	12/02/2022
Decision Date	12/29/2022
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