The following data is part of a premarket notification filed by Cramer Ent., Inc. with the FDA for Contact Lens Cleaning Accessory.
| Device ID | K923816 |
| 510k Number | K923816 |
| Device Name: | CONTACT LENS CLEANING ACCESSORY |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | CRAMER ENT., INC. TWO PACES WEST SUITE 1780 Atlanta, GA 30339 |
| Contact | Thomas W Cramer |
| Correspondent | Thomas W Cramer CRAMER ENT., INC. TWO PACES WEST SUITE 1780 Atlanta, GA 30339 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-30 |
| Decision Date | 1993-03-08 |