The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Gabriel 3 Way Enfit Valve.
| Device ID | K201741 |
| 510k Number | K201741 |
| Device Name: | Gabriel 3 Way EnFit Valve |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Syncro Medical Innovations, Inc. 515 Mulberry Street Macon, GA 31201 -6308 |
| Contact | Sabry Gabriel |
| Correspondent | Sabry Gabriel Syncro Medical Innovations, Inc. 515 Mulberry Street Macon, GA 31201 -6308 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2020-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000931366 | K201741 | 000 |