FDA 510(k) Application Details - K202523

Device Classification Name	Mouthguard, Migraine/Tension Headache   More FDA Info for this Device
510(K) Number	K202523
Device Name	Mouthguard, Migraine/Tension Headache
Applicant	Moonwalker Innovations Inc 20 Roosevelt Rd Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Charles Sutera Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2020
Decision Date	06/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review