FDA 510(k) Application Details - K082009

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K082009
Device Name	Nebulizer (Direct Patient Interface)
Applicant	HSINER CO., LTD. 29201 VIA NORTE TEMECULA, CA 92591 US Other 510(k) Applications for this Company
Contact	TOM SHANKS 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	07/23/2008
Decision Date	08/22/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review