The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Gabriel Feeding Tube With Balloon, And Enfit Connector.
| Device ID | K191784 |
| 510k Number | K191784 |
| Device Name: | Gabriel Feeding Tube With Balloon, And EnFit Connector |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Syncro Medical Innovations, Inc. 515 Mulberry St Suite 200 Macon, GA 31201 -6308 |
| Contact | Sabry Gabriel |
| Correspondent | Sabry Gabriel Syncro Medical Innovations, Inc. 515 Mulberry St Suite 200 Macon, GA 31201 -6308 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-07-03 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860000931349 | K191784 | 000 |
| 10860000931332 | K191784 | 000 |