The following data is part of a premarket notification filed by Safeway Products, Inc. with the FDA for Soft Lens Thermal Disinfecting Unit, A-c.
| Device ID | K822828 |
| 510k Number | K822828 |
| Device Name: | SOFT LENS THERMAL DISINFECTING UNIT, A-C |
| Classification | Sterilizer, Soft-lens, Thermal, Ac-powered |
| Applicant | SAFEWAY PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRD |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-21 |
| Decision Date | 1982-10-29 |