FDA 510(k) Application Details - DEN170090

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170090
Device Name	MATRx plus
Applicant	Zephyr Sleep Technologies 610A 70 Ave SE Calgary T2H-2J6 CA Other 510(k) Applications for this Company
Contact	Sabrina Bruehlmann Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2017
Decision Date	08/23/2018
Decision	DENG -
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review