FDA 510(k) Application Details - K080926

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K080926
Device Name	Nebulizer (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	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2008
Decision Date	08/12/2008
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