FDA 510(k) Application Details - K192511

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K192511
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	Venner Medical (Singapore) PTE Ltd 35 Joo Koon Circle Singapore 629110 SG Other 510(k) Applications for this Company
Contact	Adrian P Waterton Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	BTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2019
Decision Date	07/22/2020
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