FDA 510(k) Application Details - K070642

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K070642
Device Name	Nebulizer (Direct Patient Interface)
Applicant	AEROGEN (IRELAND) LTD GALWAY BUSINESS PARK DANGAN, GALWAY IE Other 510(k) Applications for this Company
Contact	FRANK ENRIGHT 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	03/08/2007
Decision Date	05/07/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review