FDA 510(k) Application Details - K241369

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K241369
Device Name	Mouthguard, Prescription
Applicant	Lijia LLC 1520 Brookhollow Dr Unit 38 Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Benjamin Li Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2024
Decision Date	08/22/2024
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