K963723 is an FDA 510(k) clearance for the LACERATION TRAY, a Tray, Surgical (Class I — General Controls, product code LRP), submitted by Grand Medical Products (Schaumburg, US). The FDA issued a Cleared decision on November 27, 1996, 72 days after receiving the submission on September 16, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K963723 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 1996 |
| Decision Date | November 27, 1996 |
| Days to Decision | 72 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 |