The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model Gft-111.
| Device ID | K072787 |
| 510k Number | K072787 |
| Device Name: | GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SYNCRO MEDICAL INNOVATIONS, INC. 342 E MAIN STREET, SUITE 207 Leola, PA 17540 |
| Contact | William Mclain |
| Correspondent | William Mclain SYNCRO MEDICAL INNOVATIONS, INC. 342 E MAIN STREET, SUITE 207 Leola, PA 17540 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-01 |
| Decision Date | 2007-10-31 |
| Summary: | summary |