K900927 is an FDA 510(k) clearance for the CODERE-DURETTE ORBITAL FLOOR IMPLANT. This device is classified as a Implant, Orbital, Extra-ocular (Class II - Special Controls, product code HQX).
Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on May 15, 1990, 77 days after receiving the submission on February 27, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3340.
| 510(k) Number | K900927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1990 |
| Decision Date | May 15, 1990 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQX — Implant, Orbital, Extra-ocular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3340 |