The following data is part of a premarket notification filed by Blairex Laboratories, Inc. with the FDA for Hard Contact Lens Cleaner.
Device ID | K832810 |
510k Number | K832810 |
Device Name: | HARD CONTACT LENS CLEANER |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | BLAIREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 | 1983-08-18 |
Decision Date | 1983-09-29 |