FDA 510(k) Application Details - K182910

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K182910
Device Name	Prosthesis, Esophageal
Applicant	Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Becky Li 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	10/17/2018
Decision Date	05/29/2019
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