FDA 510(k) Application Details - K070867

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K070867
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	INO THERAPEUTICS LLC 6 ROUTE 173 CLINTON, NJ 08809 US Other 510(k) Applications for this Company
Contact	RICHARD K BOURNE Other 510(k) Applications for this Contact
Regulation Number	868.5165   More FDA Info for this Regulation Number
Classification Product Code	MRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2007
Decision Date	04/27/2007
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