The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-one Multi-purpose Solution.
| Device ID | K983973 |
| 510k Number | K983973 |
| Device Name: | OPTI-ONE MULTI-PURPOSE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Michael Pfleger |
| Correspondent | Michael Pfleger ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 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 | 1998-11-09 |
| Decision Date | 1998-12-18 |
| Summary: | summary |