FDA 510(k) Application Details - K182739

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K182739
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	WELL LEAD MEDICAL CO., LTD. C-4 # Jinhu Industrial Estate, Hualong, Panyu Guangzhou 511434 CN Other 510(k) Applications for this Company
Contact	Huang Kaigen 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	09/28/2018
Decision Date	12/11/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review