FDA 510(k) Application Details - K233364

Device Classification Name	More FDA Info for this Device
510(K) Number	K233364
Device Name	Axon Therapy
Applicant	NeuraLace Medical Inc. 16990 Goldentop Road San Diego, CA 92127 US Other 510(k) Applications for this Company
Contact	Joe Milkovits Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2023
Decision Date	01/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review