The following data is part of a premarket notification filed by Alcon with the FDA for Opti-free Express Multi-purpose Solution.
| Device ID | K981574 |
| 510k Number | K981574 |
| Device Name: | OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Michael Pfleger |
| Correspondent | Michael Pfleger ALCON 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 | 1998-05-04 |
| Decision Date | 1998-07-06 |
| Summary: | summary |