The following data is part of a premarket notification filed by Ciba Vision Care with the FDA for In A Wink Lubricating & Rewetting Drops.
| Device ID | K853445 |
| 510k Number | K853445 |
| Device Name: | IN A WINK LUBRICATING & REWETTING DROPS |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | CIBA VISION CARE 2910 AMWILER COURT Atlanta, GA 30360 |
| Contact | Paul G Stapleton |
| Correspondent | Paul G Stapleton CIBA VISION CARE 2910 AMWILER COURT Atlanta, GA 30360 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-11-29 |