FDA 510(k) Application Details - K160694

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K160694
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	TIANJIN MEDIS MEDICAL DEVICE CO., LTD. 10-A TIANZHI INDUSTRIAL CENTER, NO. 12 HONG YUAN ROAD TIANJIN CITY 300385 CN Other 510(k) Applications for this Company
Contact	ZHENCHUANG YANG Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2016
Decision Date	04/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review