FDA 510(k) Application Details - K231209

Device Classification Name	More FDA Info for this Device
510(K) Number	K231209
Device Name	Rejoyn
Applicant	Otsuka America Pharmaceutical, Inc. 2440 Research Boulevard Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	Nancy Teague Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2023
Decision Date	03/30/2024
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