The following data is part of a premarket notification filed by Veritract, Inc. with the FDA for Veritract Enteral Feeding Tube System.
| Device ID | K133334 |
| 510k Number | K133334 |
| Device Name: | VERITRACT ENTERAL FEEDING TUBE SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VERITRACT, INC. 383 COLOROW DRIVE Salt Lake City, UT 84108 |
| Contact | Tim Nieman |
| Correspondent | Tim Nieman REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-08-26 |