FDA 510(k) Application Details - K051587

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K051587
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	TRACOE MEDICAL GMBH 117 FLANDERS ROAD WESTBOROUGH, MA 01581 US Other 510(k) Applications for this Company
Contact	MICHAEL A WARREN 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	06/15/2005
Decision Date	10/25/2005
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