FDA 510(k) Application Details - K183616

Device Classification Name	Stent, Colonic, Metalic, Expandable   More FDA Info for this Device
510(K) Number	K183616
Device Name	Stent, Colonic, Metalic, Expandable
Applicant	M.I. Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si 17706 KR Other 510(k) Applications for this Company
Contact	Inae Kim Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	MQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	01/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review