FDA 510(k) Application Details - K093469

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K093469
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	COOK, INC. 750 DANIELS WAY BLOOMINGTON, IN 47402-0489 US Other 510(k) Applications for this Company
Contact	SUSANNE GALIN 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	11/06/2009
Decision Date	01/08/2010
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