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 |