The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Akreos Single Use Insertion Device, Model Ai-28.
| Device ID | K063694 |
| 510k Number | K063694 |
| Device Name: | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 |
| Classification | Lens, Guide, Intraocular |
| Applicant | BAUSCH & LOMB, INC. 180 VIA VERDE DR. San Dimas, CA 91773 |
| Contact | Nanette Canepa |
| Correspondent | Nanette Canepa BAUSCH & LOMB, INC. 180 VIA VERDE DR. San Dimas, CA 91773 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-03-07 |
| Summary: | summary |