K944882 is an FDA 510(k) clearance for the IRRIGATION TRAY, a Tray, Irrigation, Sterile (Class II — Special Controls, product code EYN), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on January 12, 1995, 101 days after receiving the submission on October 3, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K944882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1994 |
| Decision Date | January 12, 1995 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EYN — Tray, Irrigation, Sterile |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |