FDA 510(k) Application Details - K022212

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K022212
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	MENTOR MEDICAL LIMITED MILITARY ROAD HYTHE, KENT CT21 6DB GB Other 510(k) Applications for this Company
Contact	STEVE OGILVIE Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	JOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2002
Decision Date	03/21/2003
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