The following data is part of a premarket notification filed by Optimark Accessories And Instruments with the FDA for Ophthalmic Trial Lenses.
| Device ID | K930195 |
| 510k Number | K930195 |
| Device Name: | OPHTHALMIC TRIAL LENSES |
| Classification | Set, Lens, Trial, Ophthalmic |
| Applicant | OPTIMARK ACCESSORIES AND INSTRUMENTS P.O. BOX 14115 Seattle, WA 98104 |
| Contact | Christine K Mark |
| Correspondent | Christine K Mark OPTIMARK ACCESSORIES AND INSTRUMENTS P.O. BOX 14115 Seattle, WA 98104 |
| Product Code | HPC |
| CFR Regulation Number | 886.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1994-01-06 |