FDA 510(k) Application Details - K192545

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K192545
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Jeisys Medical Incorporated 307 Daeyung Techno Town 8th; Gamasan-ro 96, Geumcheon-Gu Seoul 08501 KR Other 510(k) Applications for this Company
Contact	Wonchel Choi 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	09/16/2019
Decision Date	02/20/2020
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