The following data is part of a premarket notification filed by Eyefix, Inc. with the FDA for Eye Fixation Speculum.
| Device ID | K964289 |
| 510k Number | K964289 |
| Device Name: | EYE FIXATION SPECULUM |
| Classification | Specula, Ophthalmic |
| Applicant | EYEFIX, INC. 12300 TWINBROOK PKWY. Rockville, MD 20852 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman EYEFIX, INC. 12300 TWINBROOK PKWY. Rockville, MD 20852 |
| Product Code | HNC |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-28 |
| Decision Date | 1996-12-17 |
| Summary: | summary |