The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Compat Enteral Feed Pump 199235 & 199240.
| Device ID | K891575 |
| 510k Number | K891575 |
| Device Name: | COMPAT ENTERAL FEED PUMP 199235 & 199240 |
| Classification | Pump, Infusion, Enteral |
| Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
| Contact | Egberg, Ph.d. |
| Correspondent | Egberg, Ph.d. SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-09-12 |