FDA 510(k) Application Details - K173108

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K173108
Device Name	Apparatus, Exhaust, Surgical
Applicant	Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si 10880 KR Other 510(k) Applications for this Company
Contact	Yoojung Choi Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	05/18/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review