FDA 510(k) Application Details - K240337

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K240337
Device Name	Handpiece, Air-Powered, Dental
Applicant	Guangdong JINME Medical Technology Co., Ltd. Room 301, 401, 501, Block No.3, Wanyang Science Park, 84 Taoyuan East Rd. Shishan Town, Nanhai District Foshan 528200 CN Other 510(k) Applications for this Company
Contact	Ying Yang Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2024
Decision Date	11/13/2024
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