FDA 510(k) Application Details - K080105

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K080105
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	CHILECOM MEDICAL DEVICES CO., LTD. 155 FLEMINGTON CT. LA MIRADA, CA 90638 US Other 510(k) Applications for this Company
Contact	BRANDON CHOI 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	01/14/2008
Decision Date	02/13/2009
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