FDA 510(k) Application Details - K230968

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K230968
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul 04796 KR Other 510(k) Applications for this Company
Contact	Sunny Kang 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	04/05/2023
Decision Date	07/06/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review