K900737 is an FDA 510(k) clearance for the PISTON IRRIGATION TRAY. This device is classified as a Tray, Irrigation, Sterile (Class II - Special Controls, product code EYN).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on April 19, 1990, 62 days after receiving the submission on February 16, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K900737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 16, 1990 |
| Decision Date | April 19, 1990 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EYN — Tray, Irrigation, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |