FDA 510(k) Application Details - K231865

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K231865
Device Name	Mouthguard, Over-The-Counter
Applicant	Reazeal Corp 1226 North King St. #485 Wilmington, DE 19801 US Other 510(k) Applications for this Company
Contact	Liu Fuhua Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2023
Decision Date	11/06/2023
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