K854711 is an FDA 510(k) clearance for the FIBRELIGHT ILLUMINATING ORAL RETRACTORS. This device is classified as a Retractor, All Types (Class I - General Controls, product code EIG).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on February 25, 1986, 95 days after receiving the submission on November 22, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K854711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1985 |
| Decision Date | February 25, 1986 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIG — Retractor, All Types |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |