FDA 510(k) Application Details - K122235

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K122235
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	Teleflex Medical, Inc. 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	LORI PFOHL 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	07/26/2012
Decision Date	09/06/2013
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