FDA 510(k) Application Details - K042684

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K042684
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD 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	09/29/2004
Decision Date	02/17/2005
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