The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Entera-flo Enteral Feeding Pump.
| Device ID | K894506 |
| 510k Number | K894506 |
| Device Name: | ENTERA-FLO ENTERAL FEEDING PUMP |
| Classification | Pump, Infusion |
| Applicant | DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Revelj, R.n. |
| Correspondent | Revelj, R.n. DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1990-08-06 |