FDA 510(k) Application Details - K112010

Device Classification Name	Holding Chambers, Direct Patient Interface   More FDA Info for this Device
510(K) Number	K112010
Device Name	Holding Chambers, Direct Patient Interface
Applicant	TRUDELL MEDICAL INTL. 725 THIRD ST. LONDON, ONTARIO N5V 5G4 CA Other 510(k) Applications for this Company
Contact	DARRYL FISCHER 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	07/14/2011
Decision Date	07/11/2012
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