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FDA 510(k), K140472, BONASTENT TRACHEAL / BRONCHIAL
FDA 510(k), K140472, BONASTENT TRACHEAL / BRONCHIAL
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510(K) Number: K140472
Device Name: BONASTENT TRACHEAL / BRONCHIAL
Manufacturer: ENDOCHOICE, INC.
Device Classification Name: prosthesis, tracheal, expandable
Regulation Number: 878.3720
Classification Product Code: JCT
Date Received: 02/25/2014
Decision Date: 10/17/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BONASTENT TRACHEAL / BRONCHIAL
Manufacturer: ENDOCHOICE, INC.
Device Classification Name: prosthesis, tracheal, expandable
Regulation Number: 878.3720
Classification Product Code: JCT
Date Received: 02/25/2014
Decision Date: 10/17/2014
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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