The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Lensine Extra Strength Cleaner.
| Device ID | K812433 |
| 510k Number | K812433 |
| Device Name: | LENSINE EXTRA STRENGTH CLEANER |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| 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 | 1981-08-25 |
| Decision Date | 1981-09-21 |