FDA 510(k) Application Details - K160109

Device Classification Name	Holding Chambers, Direct Patient Interface   More FDA Info for this Device
510(K) Number	K160109
Device Name	Holding Chambers, Direct Patient Interface
Applicant	THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE ROAD SUITE 337 TUCSON, AZ 85714 US Other 510(k) Applications for this Company
Contact	MEGHAN MCGOVERN 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	01/19/2016
Decision Date	05/19/2017
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