FDA 510(k) Application Details - K230641

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K230641
Device Name	Scaler, Ultrasonic
Applicant	Guilin Refine Medical Instrument Co., Ltd. No.8-3, Information Industrial Park, High-Tech Zone, Qixing District Guilin 541004 CN Other 510(k) Applications for this Company
Contact	Chen Judong 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	03/08/2023
Decision Date	11/21/2023
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