FDA 510(k) Application Details - K102240

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K102240
Device Name	Nebulizer (Direct Patient Interface)
Applicant	AEROGEN IRELAND, LTD. M&M QUALTECH, PARKMORE BUSINESS PARK GALWAY IE Other 510(k) Applications for this Company
Contact	CAITRIONA CONNEELY 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	08/09/2010
Decision Date	11/10/2010
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