The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Two Mirror Gonio Lens.
| Device ID | K895846 |
| 510k Number | K895846 |
| Device Name: | TWO MIRROR GONIO LENS |
| Classification | Prism, Gonioscopic |
| Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Contact | Tamsin J Erickson |
| Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Product Code | HKS |
| CFR Regulation Number | 886.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238107518 | K895846 | 000 |
| 00630238107471 | K895846 | 000 |
| 00630238053440 | K895846 | 000 |
| 00630238053402 | K895846 | 000 |
| 00630238007917 | K895846 | 000 |
| 00630238007900 | K895846 | 000 |