FDA 510(k) Application Details - K201262

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K201262
Device Name	System, Ablation, Microwave And Accessories
Applicant	Nanjing ECO Microwave System Co., Ltd Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing 211800 CN Other 510(k) Applications for this Company
Contact	Hong Wei Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2020
Decision Date	07/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review