FDA 510(k) Application Details - K213251

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K213251
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	Sunyoung Jo 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	09/30/2021
Decision Date	11/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review