The following data is part of a premarket notification filed by Optikem International, Inc. with the FDA for Le Case Hard Contact Lens Storage Case.
| Device ID | K822495 |
| 510k Number | K822495 |
| Device Name: | LE CASE HARD CONTACT LENS STORAGE CASE |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | OPTIKEM INTERNATIONAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-18 |
| Decision Date | 1982-09-30 |