The following data is part of a premarket notification filed by Microdynamics with the FDA for Ocular Occluder.
| Device ID | K900942 |
| 510k Number | K900942 |
| Device Name: | OCULAR OCCLUDER |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | MICRODYNAMICS 9037 ARROW ROUTE SUITE 100 Rancho Cucamonga, CA 91730 |
| Contact | Richard Rothermund |
| Correspondent | Richard Rothermund MICRODYNAMICS 9037 ARROW ROUTE SUITE 100 Rancho Cucamonga, CA 91730 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-28 |
| Decision Date | 1990-05-25 |