K940646 is an FDA 510(k) clearance for the ORTHOPEDIC TRAY PRODUCT LINE, a Tray, Surgical (Class I — General Controls, product code LRP), submitted by Cushindu (Piney Flats, US). The FDA issued a Cleared decision on March 11, 1994, 24 days after receiving the submission on February 15, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K940646 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | February 15, 1994 |
| Decision Date | March 11, 1994 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LRP — Tray, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |