510(k) K050379

CS MEDICAL ADULT TTCF CATHETER by Cs Medical, Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2005
Date Received
February 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type