K000657 is an FDA 510(k) clearance for the LUER ACCESS UNIVERSAL VIAL ADAPTER. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 8, 2000, 9 days after receiving the submission on February 28, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K000657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2000 |
| Decision Date | March 08, 2000 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |