FDA 510(k) Application Details - K210021

Device Classification Name	More FDA Info for this Device
510(K) Number	K210021
Device Name	Axon Therapy
Applicant	NeuraLace Medical, Inc. 3770 Tansy St #101 San Diego, CA 92121 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	01/04/2021
Decision Date	06/11/2021
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