FDA 510(k) Application Details - K222096

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K222096
Device Name	Scaler, Ultrasonic
Applicant	Foshan COXO Medical Instrument Co.,Ltd. BLDG 4,District A Guangdong New Light Source Industrial Base,South of Luocun,Avenue Nanhai Foshan 528226 CN Other 510(k) Applications for this Company
Contact	Yongjian Zheng Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2022
Decision Date	03/23/2023
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