K791774 is an FDA 510(k) clearance for the LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 26, 1979, 46 days after receiving the submission on September 10, 1979.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K791774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1979 |
| Decision Date | October 26, 1979 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |