The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor Odyssey Phacoemulsification System.
| Device ID | K912904 |
| 510k Number | K912904 |
| Device Name: | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Contact | Richard L Follett |
| Correspondent | Richard L Follett MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-02 |
| Decision Date | 1992-06-11 |