FDA 510(k) Application Details - K060945

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K060945
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	SMITHS MEDICAL INTERNATIONAL 1 ST. CRISPIN WAY HASLINGDEN ROSSENDALE, LANCASHIRE BB4 4PW GB Other 510(k) Applications for this Company
Contact	STEWART LEE Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	BTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2006
Decision Date	06/19/2006
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