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 | K173538 |
510k Number | K173538 |
Device Name: | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case With AODisc |
Classification | Case, Contact Lens |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 -2099 |
Contact | Katryna Warren |
Correspondent | Ralf Finke Ciba Vision GmbH Industriering 1 Grosswallstadt, DE 63868 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-15 |
Decision Date | 2017-12-04 |
Summary: | summary |