FDA 510(k), K191784, Gabriel Feeding Tube with Balloon, and EnFit Connector

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

458 pages (450 of 908 original pages are fully redacted)