The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Gabriel Feeding Tube With Balloon, Magnetically Guided Feeding Tube W/balloon, Gabriel Feeding Tube With Balloon, Preassembled With Stylet.
| Device ID | K160787 |
| 510k Number | K160787 |
| Device Name: | Gabriel Feeding Tube With Balloon, Magnetically Guided Feeding Tube W/Balloon, Gabriel Feeding Tube With Balloon, Preassembled With Stylet |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SYNCRO MEDICAL INNOVATIONS, INC. 515 Mulberry Street, Suite 200 Macon, GA 31201 |
| Contact | Sabry Gabriel |
| Correspondent | Bill Mclain Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-03-22 |
| Decision Date | 2016-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860000931325 | K160787 | 000 |
| 10860000931318 | K160787 | 000 |
| 10860000931301 | K160787 | 000 |