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FDA 510(k), K093537, HANAROSTENT ESOPHAGUS (CCC)
FDA 510(k), K093537, HANAROSTENT ESOPHAGUS (CCC)
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510(K) Number: K093537
Device Name: HANAROSTENT ESOPHAGUS (CCC)
Manufacturer: M.I. TECH CO., LTD.
Device Classification Name: prosthesis, esophageal
Regulation Number: 878.3610
Classification Product Code: ESW
Date Received: 11/16/2009
Decision Date: 06/04/2010
Regulation Medical Specialty: General & Plastic Surgery
Device Name: HANAROSTENT ESOPHAGUS (CCC)
Manufacturer: M.I. TECH CO., LTD.
Device Classification Name: prosthesis, esophageal
Regulation Number: 878.3610
Classification Product Code: ESW
Date Received: 11/16/2009
Decision Date: 06/04/2010
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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