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FDA 510(k), K071553, ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
FDA 510(k), K071553, ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
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510(K) Number: K071553
Device Name: ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
Manufacturer: NDO SURGICAL, INC.
Device Classification Name: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation Number: 876.1500
Classification Product Code: ODE
Date Received: 06/06/2007
Decision Date: 09/18/2007
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
Manufacturer: NDO SURGICAL, INC.
Device Classification Name: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation Number: 876.1500
Classification Product Code: ODE
Date Received: 06/06/2007
Decision Date: 09/18/2007
Regulation Medical Specialty: Gastroenterology/Urology
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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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