The following data is part of a premarket notification filed by Alcon, Inc. with the FDA for Soft (hydrophilic) Contact Lens Care Solution.
| Device ID | K031193 |
| 510k Number | K031193 |
| Device Name: | SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALCON, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Kim B Kracke |
| Correspondent | Kim B Kracke ALCON, INC. 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 | 2003-04-16 |
| Decision Date | 2003-07-03 |
| Summary: | summary |