K791528 is an FDA 510(k) clearance for the FLEXIFO ENTERAL NUTRITION PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Abbott Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979, 33 days after receiving the submission on August 10, 1979.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K791528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1979 |
| Decision Date | September 12, 1979 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |