The following data is part of a premarket notification filed by Mentor Ophthalmics, Inc. with the FDA for Mentor Advent A/b System.
| Device ID | K960765 |
| 510k Number | K960765 |
| Device Name: | MENTOR ADVENT A/B SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MENTOR OPHTHALMICS, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Contact | David Downey |
| Correspondent | David Downey MENTOR OPHTHALMICS, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-08-08 |
| Summary: | summary |