FDA 510(k) Application Details - K170325

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K170325
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Ilooda Co., Ltd. 120, Jangan-ro 458 Beon-gil Jangan-Gu Suwon-Si 100-85816200 KR Other 510(k) Applications for this Company
Contact	Yun Jung Ha 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	02/02/2017
Decision Date	06/13/2017
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