FDA 510(k) Application Details - K091794

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K091794
Device Name	Nebulizer (Direct Patient Interface)
Applicant	STEVE ISLAVA 1599 SUPERIOR AVE, STE B5 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	JIM BARLEY 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	06/17/2009
Decision Date	01/28/2010
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