K800284 is an FDA 510(k) clearance for the THREE-WAY STOPCOCK EXTENSION SET 20-SL. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 26, 1980, 18 days after receiving the submission on February 8, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K800284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1980 |
| Decision Date | February 26, 1980 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |