FDA 510(k) Application Details - K082038

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K082038
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH SUITE 300 MINNEAPOLIS, MN 55427 US Other 510(k) Applications for this Company
Contact	THOMAS BARTHEL Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2008
Decision Date	04/28/2009
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	N
Expedited Review