K791531 is an FDA 510(k) clearance for the FLEXIFLO ENTERAL PUMP SET. This device is classified as a Tube, Nasogastric (Class II - Special Controls, product code BSS).
Submitted by Abbott Laboratories (Abbott Park, 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 Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K791531 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 | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |