FDA 510(k) Application Details - K221469

Device Classification Name	Block, Bite   More FDA Info for this Device
510(K) Number	K221469
Device Name	Block, Bite
Applicant	NeuroVice, LLC 7928 Woodcross Way Wake Forest, NC 27587 US Other 510(k) Applications for this Company
Contact	Ashlyn Sanders Other 510(k) Applications for this Contact
Regulation Number	882.5070   More FDA Info for this Regulation Number
Classification Product Code	JXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2022
Decision Date	02/22/2023
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