K873991 is an FDA 510(k) clearance for the LAKE IRRIGATION TRAY. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Lake Medical Products, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on December 30, 1987, 90 days after receiving the submission on October 1, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K873991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1987 |
| Decision Date | December 30, 1987 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |