The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Enternal Feeding Tube-polyurethane Ef504.
| Device ID | K844175 |
| 510k Number | K844175 |
| Device Name: | ENTERNAL FEEDING TUBE-POLYURETHANE EF504 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | EXCO, INC. P.O. BOX 1348 Wall, NJ 07719 |
| Contact | John Y Chalakani |
| Correspondent | John Y Chalakani EXCO, INC. P.O. BOX 1348 Wall, NJ 07719 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1985-01-02 |