FDA 510(k) Application Details - K090398

Device Classification Name	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea   More FDA Info for this Device
510(K) Number	K090398
Device Name	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Applicant	VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 425 BELMONT, CA 94002 US Other 510(k) Applications for this Company
Contact	MARY ROSE Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	OHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2009
Decision Date	04/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review