The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Optical Markers/fixation Ring/cannu & Irriga Cannu.
| Device ID | K861535 |
| 510k Number | K861535 |
| Device Name: | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU |
| Classification | Marker, Ocular |
| Applicant | COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Contact | Michael J Andrews |
| Correspondent | Michael J Andrews COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Product Code | HMR |
| CFR Regulation Number | 886.4570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-24 |
| Decision Date | 1986-05-14 |