K881095 is an FDA 510(k) clearance for the KOI(TM) INSTRUMENT TRAYS. This device is classified as a Tray, Surgical (Class I - General Controls, product code LRP).
Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 6, 1988, 22 days after receiving the submission on March 15, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K881095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1988 |
| Decision Date | April 06, 1988 |
| Days to Decision | 22 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 |