FDA 510(k) Application Details - K070948

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K070948
Device Name	Nebulizer (Direct Patient Interface)
Applicant	HSINER 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	04/04/2007
Decision Date	04/25/2007
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