FDA 510(k) Application Details - K062104

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K062104
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	ENGINEERED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK # 102 BONITA SPRINGS, FL 34134-2015 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	07/24/2006
Decision Date	04/20/2007
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