The following data is part of a premarket notification filed by Zevex, Inc. with the FDA for Device Modification Of Enteral Feeding Sets For Gravity And Pump Use.
| Device ID | K012147 |
| 510k Number | K012147 |
| Device Name: | DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Contact | Susan P Schmidt |
| Correspondent | Susan P Schmidt ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-10 |
| Decision Date | 2001-11-02 |
| Summary: | summary |