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510(k) K953593

RUSCH TRACHEAL BRONCHIAL Y STENT by Rusch, Inc. — Product Code NYT

Clearance Details

Decision
ST ()
Decision Date
October 13, 1995
Date Received
July 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

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