FDA 510(k) Application Details - K093135

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K093135
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	VENNER MEDICAL (SINGAPORE) PTE LTD 2626 VALLEY VIEW LANE, SUITE 4 DALLAS, TX 75234 US Other 510(k) Applications for this Company
Contact	JUDY BURTON 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	10/05/2009
Decision Date	04/02/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review