K992294 is an FDA 510(k) clearance for the BIOCERAMIC ORBITAL IMPLANT. This device is classified as a Implant, Eye Sphere (Class II - Special Controls, product code HPZ).
Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on April 19, 2000, 287 days after receiving the submission on July 7, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K992294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1999 |
| Decision Date | April 19, 2000 |
| Days to Decision | 287 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |