FDA 510(k) Application Details - K081516

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K081516
Device Name	Valve, Non-Rebreathing
Applicant	MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. MOUND, MN 55364 US Other 510(k) Applications for this Company
Regulation Number	868.5870   More FDA Info for this Regulation Number
Classification Product Code	CBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2008
Decision Date	08/26/2008
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	Y
Expedited Review