The following data is part of a premarket notification filed by Optimum Manufacturers, Inc. with the FDA for Contact Lens Case For Rigid Gas Perma.
| Device ID | K840691 |
| 510k Number | K840691 |
| Device Name: | CONTACT LENS CASE FOR RIGID GAS PERMA |
| Classification | Case, Contact Lens |
| Applicant | OPTIMUM MANUFACTURERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-16 |
| Decision Date | 1984-05-18 |