FDA 510(k) Application Details - K051416

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K051416
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	MALLINCKRODT MEDICAL 4280 HACIENDA DRIVE PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	PATRICK GARVEY 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	06/01/2005
Decision Date	06/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review