The following data is part of a premarket notification filed by Mentor Ophthalmics, Inc. with the FDA for Mentor Tono-pen 3.
| Device ID | K964312 |
| 510k Number | K964312 |
| Device Name: | MENTOR TONO-PEN 3 |
| Classification | Tonometer, Manual |
| Applicant | MENTOR OPHTHALMICS, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Contact | David M Downey |
| Correspondent | David M Downey MENTOR OPHTHALMICS, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1996-11-26 |
| Summary: | summary |