K791796 is an FDA 510(k) clearance for the ADDITIVE HINGE CAP. 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 1, 1979, 17 days after receiving the submission on September 14, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K791796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1979 |
| Decision Date | October 01, 1979 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |