The following data is part of a premarket notification filed by Blairex Laboratories, Inc. with the FDA for Benzethonium Chloride.
| Device ID | K833903 |
| 510k Number | K833903 |
| Device Name: | BENZETHONIUM CHLORIDE |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | BLAIREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1983-11-14 |
| Decision Date | 1984-05-30 |