The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Clear Care Cleaning & Disinfecting Solution, Aocup Lens Case With Aodisc.
| Device ID | K162597 |
| 510k Number | K162597 |
| Device Name: | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case With AODisc |
| Classification | Accessories, Soft Lens Products |
| Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
| Contact | Sherri Lakota |
| Correspondent | Ralf Finke CIBA VISION GMBH INDUSTRIERING 1 Grosswallstadt, DE 63868 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2016-10-19 |
| Summary: | summary |