K760497 is an FDA 510(k) clearance for the TRAY, SERVICE. This device is classified as a Tray, Surgical (Class I - General Controls, product code LRP).
Submitted by Landmark Plastics (Walker, US). The FDA issued a Cleared decision on November 12, 1976, 81 days after receiving the submission on August 23, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K760497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1976 |
| Decision Date | November 12, 1976 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LRP — Tray, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |