K915630 is an FDA 510(k) clearance for the OPHTIMPLANT. This device is classified as a Implant, Eye Sphere (Class II - Special Controls, product code HPZ).
Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on March 2, 1992, 76 days after receiving the submission on December 17, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K915630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1991 |
| Decision Date | March 02, 1992 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |