K900080 is an FDA 510(k) clearance for the NEW IOWA MOTILITY IMPLANT. 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 23, 1990, 78 days after receiving the submission on January 4, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K900080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1990 |
| Decision Date | March 23, 1990 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |