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510(k) K121048

ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED by Boston Scientific Corp — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2012
Date Received
April 6, 2012
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

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