FDA 510(k) Application Details - K193601

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K193601
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Sally He Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	07/24/2020
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