FDA 510(k) Application Details - K143615

Device Classification Name	Holding Chambers, Direct Patient Interface   More FDA Info for this Device
510(K) Number	K143615
Device Name	Holding Chambers, Direct Patient Interface
Applicant	MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED 7/56 SMITH ROAD SPRINGVALE 3171 AU Other 510(k) Applications for this Company
Contact	MAGGIE OH Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	NVP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2014
Decision Date	01/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review