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FDA 510(k), K191784, Gabriel Feeding Tube with Balloon, and EnFit Connector
FDA 510(k), K191784, Gabriel Feeding Tube with Balloon, and EnFit Connector
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$149.00 USD
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510(K) Number: K191784
Device Name: Gabriel Feeding Tube with Balloon, and EnFit Connector
Manufacturer: Syncro Medical Innovations, Inc.
Device Classification Name: Gastrointestinal Tubes With Enteral Specific Connectors
Regulation Number: 876.5980
Classification Product Code: PIF
Date Received: 07/03/2019
Decision Date: 11/15/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Gabriel Feeding Tube with Balloon, and EnFit Connector
Manufacturer: Syncro Medical Innovations, Inc.
Device Classification Name: Gastrointestinal Tubes With Enteral Specific Connectors
Regulation Number: 876.5980
Classification Product Code: PIF
Date Received: 07/03/2019
Decision Date: 11/15/2019
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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