FDA 510(k) Application Details - K240810

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K240810
Device Name	Mouthguard, Over-The-Counter
Applicant	Xiamen Yizhou Imp. & Exp. Co., Ltd. 2F, 1#, Huli Industrial Park, Meixi Road, Tong An District Xiamen 361100 CN Other 510(k) Applications for this Company
Contact	Elaine Huang 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	03/25/2024
Decision Date	05/24/2024
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