The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Enfuse Enteral Feeding Tube.
| Device ID | K922998 |
| 510k Number | K922998 |
| Device Name: | ENFUSE ENTERAL FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard T Lykins |
| Correspondent | Richard T Lykins RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1993-12-03 |