FDA 510(k) Application Details - K201160

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K201160
Device Name	Prosthesis, Esophageal
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	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2020
Decision Date	07/23/2021
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