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FDA 510(k), K080838, ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
FDA 510(k), K080838, ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
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510(K) Number: K080838
Device Name: ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Manufacturer: ALVEOLUS, INC.
Device Classification Name: prosthesis, esophageal
Regulation Number: 878.3610
Classification Product Code: ESW
Date Received: 03/25/2008
Decision Date: 04/24/2008
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Manufacturer: ALVEOLUS, INC.
Device Classification Name: prosthesis, esophageal
Regulation Number: 878.3610
Classification Product Code: ESW
Date Received: 03/25/2008
Decision Date: 04/24/2008
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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