K861535 is an FDA 510(k) clearance for the OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU. This device is classified as a Marker, Ocular (Class I - General Controls, product code HMR).
Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 14, 1986, 20 days after receiving the submission on April 24, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4570.
| 510(k) Number | K861535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1986 |
| Decision Date | May 14, 1986 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMR — Marker, Ocular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4570 |