FDA 510(k) Application Details - K060404

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K060404
Device Name	Nebulizer (Direct Patient Interface)
Applicant	MEDEL S.P.A. 112 CAVISTON WAY CARY, NC 27519 US Other 510(k) Applications for this Company
Contact	TERRENCE O'BRIEN 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	02/15/2006
Decision Date	06/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review