The following data is part of a premarket notification filed by Alcon Universal, Ltd. with the FDA for Opti-free Express Multi-purpose Disinfecting Solution.
| Device ID | K001214 |
| 510k Number | K001214 |
| Device Name: | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Michael E Pfleger |
| Correspondent | Michael E Pfleger ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-14 |
| Decision Date | 2000-07-10 |