510(k) K032744

ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM by Alveolus, Inc. — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2003
Date Received
September 4, 2003
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