The following data is part of a premarket notification filed by Optimum Manufacturers, Inc. with the FDA for Contact Lens Inserter/remover.
| Device ID | K841163 |
| 510k Number | K841163 |
| Device Name: | CONTACT LENS INSERTER/REMOVER |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | OPTIMUM MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-06-01 |