K964289 is an FDA 510(k) clearance for the EYE FIXATION SPECULUM. This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).
Submitted by Eyefix, Inc. (Rockville, US). The FDA issued a Cleared decision on December 17, 1996, 50 days after receiving the submission on October 28, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K964289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1996 |
| Decision Date | December 17, 1996 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNC — Specula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |