FDA 510(k) Application Details - K231845

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K231845
Device Name	Unit, Operative Dental
Applicant	Foshan Safety Medical Equipment Co., Ltd Floor 1,2,3, Building 6-1, Lane 1, Dianbian East Road Nanyue, Shangan, Danzao Town, Nanhai Foshan 528216 CN Other 510(k) Applications for this Company
Contact	May Xian Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2023
Decision Date	02/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review