FDA 510(k) Application Details - K201191

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K201191
Device Name	Controller, Foot, Handpiece And Cord
Applicant	MICRO-NX Co., Ltd. 22 Maeyeo-ro 1gil, Dong-gu Daegu 41059 KR Other 510(k) Applications for this Company
Contact	Jong-Kun Kee Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2020
Decision Date	02/07/2022
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