The following data is part of a premarket notification filed by Safeway Products, Inc. with the FDA for Aqualux Lens Case.
| Device ID | K862811 |
| 510k Number | K862811 |
| Device Name: | AQUALUX LENS CASE |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | SAFEWAY PRODUCTS, INC. 440 MIDDLEFIELD ST. Middletown, CT 06457 |
| Contact | Jack Howie |
| Correspondent | Jack Howie SAFEWAY PRODUCTS, INC. 440 MIDDLEFIELD ST. Middletown, CT 06457 |
| 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 | 1986-07-24 |
| Decision Date | 1986-09-03 |