510(k) K140472

BONASTENT TRACHEAL / BRONCHIAL by Endochoice, Inc. — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
February 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type